Morbid ObesityNCT03024658

Effect of Positive End Expiratory Pressure at the Time of Induction in Morbidly Obese Patients

A study testing positive end expiratory pressure (PEEP) in people with Morbid Obesity, run by Sri Aurobindo Institute of Medical Sciences.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Morbid Obesity
What is being tested?: positive end expiratory pressure (PEEP)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: No sites listed yet
Study dates: May 2015to Aug 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Anesthesia society of Anesthesiologist (ASA) physical status l, II or III,
Aged 20-65 years
BMI > 40kg/m2
scheduled for elective laparoscopic bariatric surgery

Who cannot join

Patients who denied consent
Did not fulfill the inclusion criteria,
patients undergoing Emergency and/or open surgery
Patients requiring more than 2 attempts for intubation

About this study

Official title: Single Minute of Positive End Expiratory Pressure at the Time of Induction: Effect on Arterial Blood Gases and Hemodynamics in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery

Background: Positive end expiratory pressure (PEEP) at the time of induction increases oxygenation by preventing lung atelectasis. However, PEEP may not prove beneficial in all cases. Factors affecting the action of PEEP have not been elucidated well and remain controversial. Pulmonary vasculature has direct bearing on the action of PEEP as has been proven in previous studies. Thus this study was planned to evaluate the action of PEEP on the basis of pulmonary artery systolic pressure (PASP) which is non invasive and easily measured by trans-thoracic echocardiography.

Methodology: This Randomized prospective study comprised of 70 morbidly obese patients, ASA grade II or III, aged 20-65 years with BMI > 40kg/m2, scheduled for elective laparoscopic bariatric surgery. Ten patients had to be excluded. Thus a total of 60 patients participated in the study. Thirty patients received no PEEP at the time of induction while other 30 patients were given a PEEP of 10cm of H2O. Serial ABG samples were taken pre operatively, at the time of intubation, 5 min after intubation and 10 min after intubation. Patients were then divided into four groups on the basis of PASP value of ≤ 30 mm Hg with and without PEEP or > 30 mm Hg

Read the detailed description

This prospective study was conducted in the Department Of Anaesthesiology\& Critical Care, Sri Aurobindo Institute of Medical Sciences \& P.G. Institute and Mohak Hospitals, Indore, over a period of one year. Seventy morbidly obese patients, ASA grade II or III, aged 20-65 years with BMI > 40kg/m2, scheduled for elective laparoscopic bariatric surgery were selected and a written informed consent was obtained. All the recruited patients underwent 2D-trans-thoracic echocardiography and PASP was recorded. Echocardiography was performed by same cardiologist as this measurement is operator dependent. Patients who denied consent, those undergoing Emergency and/or open surgery and those requiring more than 2 attempts for intubation were excluded.

Arterial line was inserted pre operatively and ABG sample was taken and hemodynamic parameter recording done while the patient was breathing room air. Both groups were pre-oxygenated for 3 minutes with 100% Oxygen. Standard procedure was used for induction of anesthesia in all the patients. No premedication was given. All the patients were induced with i.v. Glycopyrolate (0.005-0.01 mg/kg), i.v. Fentanyl (2µg/kg) and i.v. Propofol. Once the patient became unresponsive to verbal commands, Succinylcholine was then administered in a dose of 1- 1.5 mg/ kg. Mechanical ventilation was started with 100% oxygen. A PEEP of 10 cm H2O was applied using four hand technique in Study group while the control group received no PEEP. After one minute endotracheal intubation was done. PEEP was continued in study group after intubation.

Arterial blood gas (ABG) analysis and hemodynamic parameters were recorded at following stages:

Just after inflation of cuff of endotracheal tube
5 minutes post intubation
10 minutes post intubation

Patients were then again divided into four groups on the basis of PASP:

Group 1: Patients with PASP ≤ 30 mmHg receiving no PEEP (n= 11) Group 2: PASP ≤ 30 mm Hg receiving PEEP of 10 cm H2O (n= 11) Group 3: PASP > 30 mm Hg receiving no PEEP (n= 19) Group 4: PASP > 30 mm Hg receiving PEEP of 10 cm H2O (n=19)

Conditions: Morbid Obesity
Being tested: positive end expiratory pressure (PEEP)
Keywords: Pulmonary artery systolic pressure, Positive end expiratory pressure, morbidly obese, laparoscopic bariatric surgery
Medical subject headings: Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

positive end expiratory pressure (PEEP)Other
Positive end expiratory pressure was applied using anesthesia machine at the time of induction in the patients undergoing laparoscopic bariatric surgery

Study groups in NCT03024658
Study group	Role	What they receive
Zero PEEP	No intervention	This group of patients did not receive any PEEP at the time of induction of general anesthesia (n= 30)
PEEP- 10 cm of H2O	Experimental	This group comprised of patients who received a PEEP of 10 cm H2O at the time of induction of general anesthesia (n= 30) Receives: Other: positive end expiratory pressure (PEEP)

What is being measured

The primary outcome is the main question the study is designed to answer.

effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater
Measured: Arterial oxygenation (PaO2) in mm Hg recorded preoperatively and taken as baseline value
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia
Arterial carbon di oxide (PaCO2) values in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater
Measured: Arterial carbon di oxide (PaCO2) in mm Hg was recorded from ABG preoperatively and taken as baseline value
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia
Pulse Rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater
Measured: Pulse Rate (beats/ min) was recorded from ABG preoperatively and taken as baseline value
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia
Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater
Measured: Systolic BP in mm Hg was recorded from ABG preoperatively and taken as baseline value
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia
Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater
Measured: Diastolic BP in mm Hg was recorded from ABG preoperatively and taken as baseline value
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube
Measured: Arterial oxygenation (PaO2) in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube
Measured: Arterial carbon di oxide (PaCO2) in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube
Measured: Pulse rate (beats/ min) was recorded just after the placement and cuff inflation of endotracheal tube
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube
Measured: Systolic BP in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube
Measured: Diastolic BP in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation
Measured: Arterial oxygenation (PaO2) in mm Hg was recorded five minutes post intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation
Measured: Arterial carbon di oxide (PaCO2) in mm Hg was recorded five minutes post intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation
Measured: Pulse rate (beats/ min) was recorded five minutes post intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation
Measured: Systolic BP in mm Hg was recorded five minutes post intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation
Measured: Diastolic BP in mm Hg was recorded five minutes post intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation
Measured: Arterial oxygenation (PaO2) in mm Hg was recorded ten minutes post intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation
Measured: Arterial carbon di oxide (PaCO2) in mm Hg was recorded ten minutes post intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation
Measured: pulse Rate (beats/ min) was recorded ten minutes post intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation
Measured: Systolic BP in mm Hg was recorded ten minutes post intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation
Measured: Diastolic BP in mm Hg was recorded ten minutes post intubation

Secondary outcomes (20)

Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Preoperative arterial oxygenation was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Preoperative arterial carbon di oxide was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Preoperative pulse rate was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Systolic blood pressure was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Diastolic blood pressure was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Arterial oxygenation recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Arterial carbon di oxide (mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Pulse rate (beats/ min) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameters was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Systolic pressure(mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Diastolic blood pressure(mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Arterial oxygenation recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded five minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Arterial carbon di oxide (mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded five minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Pulse rate (beats/ min) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded five minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Systolic pressure(mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded five minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Diastolic blood pressure(mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded five minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Arterial oxygenation (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded ten minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Arterial carbon di oxide (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded ten minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Pulse rate (beats/ min) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded ten minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Systolic blood pressure (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded ten minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Diastolic blood pressure(mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
Measured: ABG and hemodynamic parameters were recorded ten minutes post intubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Aug 2016

First posted19 Jan 2017 (estimated)
Study startMay 2015
Primary completionJun 2016
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Morbid ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03024658
Sponsor's protocol ID: Saims/IEC/14/02/35
Status last verified: Jan 2017
First submitted: 6 Jan 2017
Last updated: 19 Jan 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: data was recorded on a planned proforma. Masterchart was prepared on completion which is available for sharing.

Publications

Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.
PubMed 19809292
Pelosi P, Croci M, Ravagnan I, Cerisara M, Vicardi P, Lissoni A, Gattinoni L. Respiratory system mechanics in sedated, paralyzed, morbidly obese patients. J Appl Physiol (1985). 1997 Mar;82(3):811-8. doi: 10.1152/jappl.1997.82.3.811.
PubMed 9074968
Eichenberger A, Proietti S, Wicky S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Morbid obesity and postoperative pulmonary atelectasis: an underestimated problem. Anesth Analg. 2002 Dec;95(6):1788-92, table of contents. doi: 10.1097/00000539-200212000-00060.
PubMed 12456460
Coussa M, Proietti S, Schnyder P, Frascarolo P, Suter M, Spahn DR, Magnusson L. Prevention of atelectasis formation during the induction of general anesthesia in morbidly obese patients. Anesth Analg. 2004 May;98(5):1491-5, table of contents. doi: 10.1213/01.ane.0000111743.61132.99.
PubMed 15105237
Almarakbi WA, Fawzi HM, Alhashemi JA. Effects of four intraoperative ventilatory strategies on respiratory compliance and gas exchange during laparoscopic gastric banding in obese patients. Br J Anaesth. 2009 Jun;102(6):862-8. doi: 10.1093/bja/aep084. Epub 2009 Apr 29.
PubMed 19403595
Pelosi P, Goldner M, McKibben A, Adams A, Eccher G, Caironi P, Losappio S, Gattinoni L, Marini JJ. Recruitment and derecruitment during acute respiratory failure: an experimental study. Am J Respir Crit Care Med. 2001 Jul 1;164(1):122-30. doi: 10.1164/ajrccm.164.1.2007010.
PubMed 11435250
Luecke T, Roth H, Joachim A, Herrmann P, Deventer B, Weisser G, Pelosi P, Quintel M. Effects of end-inspiratory and end-expiratory pressures on alveolar recruitment and derecruitment in saline-washout-induced lung injury -- a computed tomography study. Acta Anaesthesiol Scand. 2004 Jan;48(1):82-92. doi: 10.1111/j.1399-6576.2004.00265.x.
PubMed 14674978
Gattinoni L, Pesenti A, Bombino M, Baglioni S, Rivolta M, Rossi F, Rossi G, Fumagalli R, Marcolin R, Mascheroni D, et al. Relationships between lung computed tomographic density, gas exchange, and PEEP in acute respiratory failure. Anesthesiology. 1988 Dec;69(6):824-32. doi: 10.1097/00000542-198812000-00005.
PubMed 3057937
Maggiore SM, Jonson B, Richard JC, Jaber S, Lemaire F, Brochard L. Alveolar derecruitment at decremental positive end-expiratory pressure levels in acute lung injury: comparison with the lower inflection point, oxygenation, and compliance. Am J Respir Crit Care Med. 2001 Sep 1;164(5):795-801. doi: 10.1164/ajrccm.164.5.2006071.
PubMed 11549535
Gattinoni L, Pesenti A, Baglioni S, Vitale G, Rivolta M, Pelosi P. Inflammatory pulmonary edema and positive end-expiratory pressure: correlations between imaging and physiologic studies. J Thorac Imaging. 1988 Jul;3(3):59-64. doi: 10.1097/00005382-198807000-00013.
PubMed 3292784
Fougeres E, Teboul JL, Richard C, Osman D, Chemla D, Monnet X. Hemodynamic impact of a positive end-expiratory pressure setting in acute respiratory distress syndrome: importance of the volume status. Crit Care Med. 2010 Mar;38(3):802-7. doi: 10.1097/CCM.0b013e3181c587fd.
PubMed 19926983
McQuillan BM, Picard MH, Leavitt M, Weyman AE. Clinical correlates and reference intervals for pulmonary artery systolic pressure among echocardiographically normal subjects. Circulation. 2001 Dec 4;104(23):2797-802. doi: 10.1161/hc4801.100076.
PubMed 11733397

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Morbid Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Minute of Positive End Expiratory Pressure at the Time of Induction: Effect on Arterial Blood Gases and Hemodynamics in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery
ClinicalTrials.gov ID: NCT03024658
Acronym / sponsor ID: Saims/IEC/14/02/35
Conditions: Morbid Obesity
Keywords: Pulmonary artery systolic pressure, Positive end expiratory pressure, morbidly obese, laparoscopic bariatric surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Sri Aurobindo Institute of Medical SciencesUniversity, hospital or other
Study start: May 2015
Primary completion: Jun 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 19 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Arterial blood gas (ABG) analysis and hemodynamic parameters were recorded at following stages:

Just after inflation of cuff of endotracheal tube
5 minutes post intubation
10 minutes post intubation

Patients were then again divided into four groups on the basis of PASP:

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Zero PEEP	No intervention	–This group of patients did not receive any PEEP at the time of induction of general anesthesia (n= 30)
PEEP- 10 cm of H2O	Experimental	Other: positive end expiratory pressure (PEEP)This group comprised of patients who received a PEEP of 10 cm H2O at the time of induction of general anesthesia (n= 30)

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Anesthesia society of Anesthesiologist (ASA) physical status l, II or III,
Aged 20-65 years
BMI > 40kg/m2
scheduled for elective laparoscopic bariatric surgery

Key exclusion criteria (4 listed)

Patients who denied consent
Did not fulfill the inclusion criteria,
patients undergoing Emergency and/or open surgery
Patients requiring more than 2 attempts for intubation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
positive end expiratory pressure (PEEP)Positive end expiratory pressure was applied using anesthesia machine at the time of induction in the patients undergoing laparoscopic bariatric surgery	Other	PEEP- 10 cm of H2O

Primary outcome

effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Time frame: Arterial oxygenation (PaO2) in mm Hg recorded preoperatively and taken as baseline value
Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia
Time frame: Arterial carbon di oxide (PaCO2) in mm Hg was recorded from ABG preoperatively and taken as baseline value
Arterial carbon di oxide (PaCO2) values in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia
Time frame: Pulse Rate (beats/ min) was recorded from ABG preoperatively and taken as baseline value
Pulse Rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia
Time frame: Systolic BP in mm Hg was recorded from ABG preoperatively and taken as baseline value
Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia
Time frame: Diastolic BP in mm Hg was recorded from ABG preoperatively and taken as baseline value
Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Time frame: Arterial oxygenation (PaO2) in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube
Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Time frame: Arterial carbon di oxide (PaCO2) in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube
Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Time frame: Pulse rate (beats/ min) was recorded just after the placement and cuff inflation of endotracheal tube
Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Time frame: Systolic BP in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube
Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Time frame: Diastolic BP in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube
Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Time frame: Arterial oxygenation (PaO2) in mm Hg was recorded five minutes post intubation
Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Time frame: Arterial carbon di oxide (PaCO2) in mm Hg was recorded five minutes post intubation
Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Time frame: Pulse rate (beats/ min) was recorded five minutes post intubation
Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Time frame: Systolic BP in mm Hg was recorded five minutes post intubation
Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Time frame: Diastolic BP in mm Hg was recorded five minutes post intubation
Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Time frame: Arterial oxygenation (PaO2) in mm Hg was recorded ten minutes post intubation
Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Time frame: Arterial carbon di oxide (PaCO2) in mm Hg was recorded ten minutes post intubation
Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Time frame: pulse Rate (beats/ min) was recorded ten minutes post intubation
Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Time frame: Systolic BP in mm Hg was recorded ten minutes post intubation
Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation
effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
Time frame: Diastolic BP in mm Hg was recorded ten minutes post intubation
Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation

20 secondary outcomes

Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded five minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded five minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded five minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded five minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded five minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded ten minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded ten minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded ten minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded ten minutes post intubation
Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
Time frame: ABG and hemodynamic parameters were recorded ten minutes post intubation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
Background: PubMed 19809292Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.
Results publication: PubMed 9074968Pelosi P, Croci M, Ravagnan I, Cerisara M, Vicardi P, Lissoni A, Gattinoni L. Respiratory system mechanics in sedated, paralyzed, morbidly obese patients. J Appl Physiol (1985). 1997 Mar;82(3):811-8. doi: 10.1152/jappl.1997.82.3.811.
Results publication: PubMed 12456460Eichenberger A, Proietti S, Wicky S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Morbid obesity and postoperative pulmonary atelectasis: an underestimated problem. Anesth Analg. 2002 Dec;95(6):1788-92, table of contents. doi: 10.1097/00000539-200212000-00060.
Results publication: PubMed 15105237Coussa M, Proietti S, Schnyder P, Frascarolo P, Suter M, Spahn DR, Magnusson L. Prevention of atelectasis formation during the induction of general anesthesia in morbidly obese patients. Anesth Analg. 2004 May;98(5):1491-5, table of contents. doi: 10.1213/01.ane.0000111743.61132.99.
Results publication: PubMed 19403595Almarakbi WA, Fawzi HM, Alhashemi JA. Effects of four intraoperative ventilatory strategies on respiratory compliance and gas exchange during laparoscopic gastric banding in obese patients. Br J Anaesth. 2009 Jun;102(6):862-8. doi: 10.1093/bja/aep084. Epub 2009 Apr 29.
Results publication: PubMed 11435250Pelosi P, Goldner M, McKibben A, Adams A, Eccher G, Caironi P, Losappio S, Gattinoni L, Marini JJ. Recruitment and derecruitment during acute respiratory failure: an experimental study. Am J Respir Crit Care Med. 2001 Jul 1;164(1):122-30. doi: 10.1164/ajrccm.164.1.2007010.
Results publication: PubMed 14674978Luecke T, Roth H, Joachim A, Herrmann P, Deventer B, Weisser G, Pelosi P, Quintel M. Effects of end-inspiratory and end-expiratory pressures on alveolar recruitment and derecruitment in saline-washout-induced lung injury -- a computed tomography study. Acta Anaesthesiol Scand. 2004 Jan;48(1):82-92. doi: 10.1111/j.1399-6576.2004.00265.x.
Results publication: PubMed 3057937Gattinoni L, Pesenti A, Bombino M, Baglioni S, Rivolta M, Rossi F, Rossi G, Fumagalli R, Marcolin R, Mascheroni D, et al. Relationships between lung computed tomographic density, gas exchange, and PEEP in acute respiratory failure. Anesthesiology. 1988 Dec;69(6):824-32. doi: 10.1097/00000542-198812000-00005.
Results publication: PubMed 11549535Maggiore SM, Jonson B, Richard JC, Jaber S, Lemaire F, Brochard L. Alveolar derecruitment at decremental positive end-expiratory pressure levels in acute lung injury: comparison with the lower inflection point, oxygenation, and compliance. Am J Respir Crit Care Med. 2001 Sep 1;164(5):795-801. doi: 10.1164/ajrccm.164.5.2006071.
Results publication: PubMed 3292784Gattinoni L, Pesenti A, Baglioni S, Vitale G, Rivolta M, Pelosi P. Inflammatory pulmonary edema and positive end-expiratory pressure: correlations between imaging and physiologic studies. J Thorac Imaging. 1988 Jul;3(3):59-64. doi: 10.1097/00005382-198807000-00013.
Results publication: PubMed 19926983Fougeres E, Teboul JL, Richard C, Osman D, Chemla D, Monnet X. Hemodynamic impact of a positive end-expiratory pressure setting in acute respiratory distress syndrome: importance of the volume status. Crit Care Med. 2010 Mar;38(3):802-7. doi: 10.1097/CCM.0b013e3181c587fd.
Results publication: PubMed 11733397McQuillan BM, Picard MH, Leavitt M, Weyman AE. Clinical correlates and reference intervals for pulmonary artery systolic pressure among echocardiographically normal subjects. Circulation. 2001 Dec 4;104(23):2797-802. doi: 10.1161/hc4801.100076.
Individual participant dataSharing planned: Yes. data was recorded on a planned proforma. Masterchart was prepared on completion which is available for sharing.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing positive end expiratory pressure (PEEP) in people with Morbid Obesity, run by Sri Aurobindo Institute of Medical Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction (time frame: Arterial oxygenation (PaO2) in mm Hg recorded preoperatively and taken as baseline value). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03024658, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.