AtelectasisNCT03438383

Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery

A study testing Bi-PAP in people with Atelectasis and Pulmonary Infection, run by Evangelismos Hospital.

Completed

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

Trial summary

The effect of biphasic positive airway pressure (Bi-PAP) at individualized pressures on the postoperative pulmonary recovery of morbidly obese patients (MOP) undergoing open bariatric surgery (OBS) and possible placebo device-related effects (sham-Bi-PAP) were investigated. Read more about this study

Who is it for?: Any age
Conditions the study is for: Atelectasis, Pulmonary Infection, Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: Bi-PAP
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: No sites listed yet
Study dates: 23 May 2011to 31 May 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

All patients have been Morbidly Obese (BMI> 40kg/m2) for at least 10 years
All patients had unsuccessfully tried to lose weight by other non-invasive means.
All patients enrolled were continuous positive airway pressure (CPAP) and Bi-PAP naïve and had no knowledge about the Bi-PAP apparatus prior to enrollment
All patients underwent OBS (gastroplasty by Mason or gastric bypass) by the same operating team
All patients were treated with the same standard anesthetic protocol

Who cannot join

Cardiovascular and pulmonary disease not related to obesity status
Chronic renal disease
Patients who were initially enrolled but did not use the allocated device (Bi-PAP or Sham Bi-PAP) for at least 12 h daily were also excluded at a later point.

About this study

Official title: The Effect of Bi-PAP at Individualized Pressures on the Postoperative Pulmonary Recovery of Morbidly Obese Patients (MOP) Undergoing Open Bariatric Surgery (OBS) and Possible Placebo Device-related Effects (Sham-Bi-PAP)

Read the detailed description

In the present study the effect of Bi-PAP on the postoperative respiratory function and related complications of MOP undergoing OBS through a randomized sham-controlled design was investigated. Bi-PAP was applied at individualized pressures in order to optimize respiratory support and sham Bi-PAP was also used in order to neutralize possible placebo device related effect and researcher related bias.

The investigators hypothesized that the use of Bi-PAP at individualized pressures in MOP undergoing OBS, ameliorates postoperative respiratory function as well as diminishes related pulmonary complications, postoperative pain and duration of hospitalization. Primary endpoints were the difference in pre- and postoperative measurements of certain pulmonary function parameters (forced expiratory volume at one second (FEV1), forced vital capacity (FVC), peak expiratory flow rate (PEFR) and oxygen saturation by pulse oximetry (SpO2) and the incidence of certain pulmonary complications postoperatively (hypoxemia, atelectasis, lower respiratory tract infections). Secondary endpoints were postoperative pain and days of hospitalization.

Conditions: Atelectasis, Pulmonary Infection, Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Disease, Hypoxemic Respiratory Failure, Hypoxemia
Being tested: Bi-PAP, Sham Bi-PAP
Keywords: Bi-PAP, BiPAP, morbid obesity, anesthesia, bariatric surgery, sham Bi-PAP, sham BiPAP, postoperative complications
Medical subject headings: Pulmonary Atelectasis, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiratory Insufficiency, Hypoxia, Obesity, Morbid, Postoperative Complications

What participants receive

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

Bi-PAPDevice
The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.
Sham Bi-PAPDevice
Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.

Study groups in NCT03438383
Study group	Role	What they receive
Sham Bi-PAP	Sham comparator	Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 centimeter of water (cm H2O). Receives: Device: Sham Bi-PAP
Bi-PAP	Active comparator	Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O. Receives: Device: Bi-PAP

What is being measured

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

Forced Expiratory Volume at One Second (FEV1) Difference
difference in FEV1 value measured by spirometry pre- and post-operatively
Measured: 24 h before surgery and at 24, 48 and 72 h post-operatively
Forced Vital Capacity (FVC) Difference
difference in FVC value measured by spirometry pre- and post-operatively
Measured: 24 h before surgery and at 24, 48 and 72 hours post-operatively
Peak Expiratory Flow Rate (PEFR) Difference
difference in PEFR value measured by spirometry pre- and post-operatively
Measured: 24 h before surgery and at 24, 48 and 72 hours post-operatively
SpO2 Difference
difference in SpO2 value measured by spirometry pre- and post-operatively
Measured: 24 h before surgery and at 24, 48 and 72 hours post-operatively
Number of Participants With Hypoxemia
occurrence of hypoxemia, considered as SpO2<90%, post-operatively
Measured: At 24, 48 and 72 hours post-operatively
Number of Participants With Atelectasis
occurrence of atelectasis as defined by chest X-ray (CXR) post-operatively with CXR before surgery as baseline
Measured: At 24, 48 and 72 hours post-operatively

Secondary outcomes (2)

Post-operative Pain
Intensity of pain was assessed post-operatively by Numerical Rating Scale (NRS) (0-10, 0=no pain, 10=worst pain imaginable)
Measured: right before spirometry, at 24, 48 and 72 h post-operatively
Days of Hospitalization
duration of hospitalization, calculated by discharge date minus admission date
Measured: From day of admission to day of discharge from the hospital

Timeline

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

23 May 201131 May 2012

First posted19 Feb 2018
Study start23 May 2011
Primary completion22 May 2012
Study completion31 May 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (40)Papers the sponsor has linked to this study.
Other trials for AtelectasisStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients were assigned into the following two study groups postoperatively: 1. Sham Bi-PAP (control group) group in which sham Bi-PAP was applied through nasal mask for 3 days postoperatively. 2. Bi-PAP group in which Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. 1 patient was initially enrolled in the protocol but was excluded from the participant flow design because of recent onset of cardiovascular disease (CAD).
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03438383
Sponsor's protocol ID: 142/23-05-2011
Status last verified: Nov 2020
First submitted: 5 Feb 2018
Last updated: 16 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Parameswaran K, Todd DC, Soth M. Altered respiratory physiology in obesity. Can Respir J. 2006 May-Jun;13(4):203-10. doi: 10.1155/2006/834786.
PubMed 16779465
Salome CM, King GG, Berend N. Physiology of obesity and effects on lung function. J Appl Physiol (1985). 2010 Jan;108(1):206-11. doi: 10.1152/japplphysiol.00694.2009. Epub 2009 Oct 29.
PubMed 19875713
Gifford AH, Leiter JC, Manning HL. Respiratory function in an obese patient with sleep-disordered breathing. Chest. 2010 Sep;138(3):704-15. doi: 10.1378/chest.09-3030. No abstract available.
PubMed 20822992
Littleton SW. Impact of obesity on respiratory function. Respirology. 2012 Jan;17(1):43-9. doi: 10.1111/j.1440-1843.2011.02096.x.
PubMed 22040049
Hans GA, Lauwick S, Kaba A, Brichant JF, Joris JL. Postoperative respiratory problems in morbidly obese patients. Acta Anaesthesiol Belg. 2009;60(3):169-75.
PubMed 19961114
Lawrence VA, Dhanda R, Hilsenbeck SG, Page CP. Risk of pulmonary complications after elective abdominal surgery. Chest. 1996 Sep;110(3):744-50. doi: 10.1378/chest.110.3.744.
PubMed 8797421
Simonneau G, Vivien A, Sartene R, Kunstlinger F, Samii K, Noviant Y, Duroux P. Diaphragm dysfunction induced by upper abdominal surgery. Role of postoperative pain. Am Rev Respir Dis. 1983 Nov;128(5):899-903. doi: 10.1164/arrd.1983.128.5.899.
PubMed 6638679
Vassilakopoulos T, Mastora Z, Katsaounou P, Doukas G, Klimopoulos S, Roussos C, Zakynthinos S. Contribution of pain to inspiratory muscle dysfunction after upper abdominal surgery: A randomized controlled trial. Am J Respir Crit Care Med. 2000 Apr;161(4 Pt 1):1372-5. doi: 10.1164/ajrccm.161.4.9907082.
PubMed 10764336
Pelosi P, Gregoretti C. Perioperative management of obese patients. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):211-25. doi: 10.1016/j.bpa.2010.02.001.
PubMed 20608558
Loadsman JA, Hillman DR. Anaesthesia and sleep apnoea. Br J Anaesth. 2001 Feb;86(2):254-66. doi: 10.1093/bja/86.2.254.
PubMed 11573670
Cullen A, Ferguson A. Perioperative management of the severely obese patient: a selective pathophysiological review. Can J Anaesth. 2012 Oct;59(10):974-96. doi: 10.1007/s12630-012-9760-2. Epub 2012 Jul 26.
PubMed 22833138
Casati A, Putzu M. Anesthesia in the obese patient: pharmacokinetic considerations. J Clin Anesth. 2005 Mar;17(2):134-45. doi: 10.1016/j.jclinane.2004.01.009.
PubMed 15809132
Kyzer S, Ramadan E, Gersch M, Chaimoff C. Patient-Controlled Analgesia Following Vertical Gastroplasty: a Comparison with Intramuscular Narcotics. Obes Surg. 1995 Feb;5(1):18-21. doi: 10.1381/096089295765558097.
PubMed 10733789
Charghi R, Backman S, Christou N, Rouah F, Schricker T. Patient controlled i.v. analgesia is an acceptable pain management strategy in morbidly obese patients undergoing gastric bypass surgery. A retrospective comparison with epidural analgesia. Can J Anaesth. 2003 Aug-Sep;50(7):672-8. doi: 10.1007/BF03018709.
PubMed 12944441
Nguyen NT, Lee SL, Goldman C, Fleming N, Arango A, McFall R, Wolfe BM. Comparison of pulmonary function and postoperative pain after laparoscopic versus open gastric bypass: a randomized trial. J Am Coll Surg. 2001 Apr;192(4):469-76; discussion 476-7. doi: 10.1016/s1072-7515(01)00822-5.
PubMed 11294404

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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Right Ventricular Function, Prone Position
Recruiting
Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Atelectasis, Mechanical Ventilation
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
Not yet recruiting
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All Atelectasis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Bi-PAP at Individualized Pressures on the Postoperative Pulmonary Recovery of Morbidly Obese Patients (MOP) Undergoing Open Bariatric Surgery (OBS) and Possible Placebo Device-related Effects (Sham-Bi-PAP)
ClinicalTrials.gov ID: NCT03438383
Acronym / sponsor ID: 142/23-05-2011
Conditions: Atelectasis, Pulmonary Infection, Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Disease, Hypoxemic Respiratory Failure, Hypoxemia
Keywords: Bi-PAP, BiPAP, morbid obesity, anesthesia, bariatric surgery, sham Bi-PAP, sham BiPAP, postoperative complications
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Evangelismos HospitalUniversity, hospital or other
Collaborators: Elpis General Hospital, Sotiria General Hospital, Evgenidion Hospital
Study start: 23 May 2011 (actual)
Primary completion: 22 May 2012 (actual)
Study completion: 31 May 2012 (actual)
First posted: 19 Feb 2018 (actual)
Results: Posted 19 Mar 2020

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Patients were assigned into the following two study groups postoperatively: 1. Sham Bi-PAP (control group) group in which sham Bi-PAP was applied through nasal mask for 3 days postoperatively. 2. Bi-PAP group in which Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. 1 patient was initially enrolled in the protocol but was excluded from the participant flow design because of recent onset of cardiovascular disease (CAD).

Arm	Type	Receives
Sham Bi-PAP	Sham comparator	Device: Sham Bi-PAPSham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 centimeter of water (cm H2O).
Bi-PAP	Active comparator	Device: Bi-PAPBi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

All patients have been Morbidly Obese (BMI> 40kg/m2) for at least 10 years
All patients had unsuccessfully tried to lose weight by other non-invasive means.
All patients enrolled were continuous positive airway pressure (CPAP) and Bi-PAP naïve and had no knowledge about the Bi-PAP apparatus prior to enrollment
All patients underwent OBS (gastroplasty by Mason or gastric bypass) by the same operating team
All patients were treated with the same standard anesthetic protocol

Key exclusion criteria (3 listed)

Cardiovascular and pulmonary disease not related to obesity status
Chronic renal disease
Patients who were initially enrolled but did not use the allocated device (Bi-PAP or Sham Bi-PAP) for at least 12 h daily were also excluded at a later point.

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
Bi-PAPThe Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.	Device	Bi-PAP
Sham Bi-PAPSham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.	Device	Sham Bi-PAP

Primary outcome

Forced Expiratory Volume at One Second (FEV1) Difference
Time frame: 24 h before surgery and at 24, 48 and 72 h post-operatively
difference in FEV1 value measured by spirometry pre- and post-operatively
Forced Vital Capacity (FVC) Difference
Time frame: 24 h before surgery and at 24, 48 and 72 hours post-operatively
difference in FVC value measured by spirometry pre- and post-operatively
Peak Expiratory Flow Rate (PEFR) Difference
Time frame: 24 h before surgery and at 24, 48 and 72 hours post-operatively
difference in PEFR value measured by spirometry pre- and post-operatively
SpO2 Difference
Time frame: 24 h before surgery and at 24, 48 and 72 hours post-operatively
difference in SpO2 value measured by spirometry pre- and post-operatively
Number of Participants With Hypoxemia
Time frame: At 24, 48 and 72 hours post-operatively
occurrence of hypoxemia, considered as SpO2<90%, post-operatively
Number of Participants With Atelectasis
Time frame: At 24, 48 and 72 hours post-operatively
occurrence of atelectasis as defined by chest X-ray (CXR) post-operatively with CXR before surgery as baseline

2 secondary outcomes

Post-operative Pain
Time frame: right before spirometry, at 24, 48 and 72 h post-operatively
Days of Hospitalization
Time frame: From day of admission to day of discharge from the hospital

Results and safety

Results posted to the registry on 19 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham Bi-PAP	23	14
Bi-PAP	24	21

Primary outcome: Forced Expiratory Volume at One Second (FEV1) Difference

Time frame: 24 h before surgery and at 24, 48 and 72 h post-operatively. Mean (Standard Deviation). Unit: Litres

Measure	Sham Bi-PAP n = 14	Bi-PAP n = 21
24h before surgery	3.1 (0.7)	3.1 (0.6)
24h post-op	1.3 (0.5)	1.4 (0.3)
48h post-op	1.3 (0.4)	1.7 (0.4)
72h post-op	1.4 (0.5)	1.9 (0.4)

Sham Bi-PAP vs Bi-PAP: p = 0.88, ANOVA
Sham Bi-PAP vs Bi-PAP: p = 0.23, ANOVA
Sham Bi-PAP vs Bi-PAP: p = 0.008, ANOVA

Primary outcome: Forced Vital Capacity (FVC) Difference

Time frame: 24 h before surgery and at 24, 48 and 72 hours post-operatively. Mean (Standard Deviation). Unit: Litres

Measure	Sham Bi-PAP n = 14	Bi-PAP n = 21
24h before surgery	3.4 (1.0)	3.5 (0.7)
24h post-op	1.3 (0.4)	1.6 (0.4)
48h post-op	1.5 (0.5)	2.0 (0.4)
72h post-op	1.9 (0.6)	2.3 (0.4)

Sham Bi-PAP vs Bi-PAP: p = 0.75, ANOVA
Sham Bi-PAP vs Bi-PAP: p = 0.09, ANOVA
Sham Bi-PAP vs Bi-PAP: p = 0.008, ANOVA

Primary outcome: Peak Expiratory Flow Rate (PEFR) Difference

Time frame: 24 h before surgery and at 24, 48 and 72 hours post-operatively. Mean (Standard Deviation). Unit: Litres/minute

Measure	Sham Bi-PAP n = 14	Bi-PAP n = 21
24h before surgery	376.9 (71.7)	325.3 (75.2)
24h post-op	146.9 (61.4)	137.4 (30.5)
48h post-op	166.0 (68.1)	195.7 (46.0)
72h post-op	190.1 (64.2)	247.5 (60.5)

Sham Bi-PAP vs Bi-PAP: p = 0.05, ANOVA
Sham Bi-PAP vs Bi-PAP: p = 0.55, ANOVA
Sham Bi-PAP vs Bi-PAP: p = 0.13, ANOVA

Primary outcome: SpO2 Difference

Time frame: 24 h before surgery and at 24, 48 and 72 hours post-operatively. Mean (Standard Deviation). Unit: percentage of SpO2

Measure	Sham Bi-PAP n = 14	Bi-PAP n = 21
24h before surgery	96.9 (0.7)	96.9 (1.1)
24h post-op	91.6 (3.5)	92.6 (3.2)
48h post-op	92.4 (3.5)	95.2 (1.9)
72h post-op	92.5 (3.7)	96.8 (1.0)

Sham Bi-PAP vs Bi-PAP: p = 0.83, ANOVA
Sham Bi-PAP vs Bi-PAP: p = 0.37, ANOVA
Sham Bi-PAP vs Bi-PAP: p = 0.0035, ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1 year after study completion.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham Bi-PAP	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Bi-PAP	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Limitations and caveats (from the sponsor): The small sample size in both groups, although calculated to provide adequate statistical power; low tolerance of the Bi-PAP device, which led to the exclusion of some subjects from the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16779465Parameswaran K, Todd DC, Soth M. Altered respiratory physiology in obesity. Can Respir J. 2006 May-Jun;13(4):203-10. doi: 10.1155/2006/834786.
Background: PubMed 19875713Salome CM, King GG, Berend N. Physiology of obesity and effects on lung function. J Appl Physiol (1985). 2010 Jan;108(1):206-11. doi: 10.1152/japplphysiol.00694.2009. Epub 2009 Oct 29.
Background: PubMed 20822992Gifford AH, Leiter JC, Manning HL. Respiratory function in an obese patient with sleep-disordered breathing. Chest. 2010 Sep;138(3):704-15. doi: 10.1378/chest.09-3030. No abstract available.
Background: PubMed 22040049Littleton SW. Impact of obesity on respiratory function. Respirology. 2012 Jan;17(1):43-9. doi: 10.1111/j.1440-1843.2011.02096.x.
Background: PubMed 19961114Hans GA, Lauwick S, Kaba A, Brichant JF, Joris JL. Postoperative respiratory problems in morbidly obese patients. Acta Anaesthesiol Belg. 2009;60(3):169-75.
Background: PubMed 8797421Lawrence VA, Dhanda R, Hilsenbeck SG, Page CP. Risk of pulmonary complications after elective abdominal surgery. Chest. 1996 Sep;110(3):744-50. doi: 10.1378/chest.110.3.744.
Background: PubMed 6638679Simonneau G, Vivien A, Sartene R, Kunstlinger F, Samii K, Noviant Y, Duroux P. Diaphragm dysfunction induced by upper abdominal surgery. Role of postoperative pain. Am Rev Respir Dis. 1983 Nov;128(5):899-903. doi: 10.1164/arrd.1983.128.5.899.
Background: PubMed 10764336Vassilakopoulos T, Mastora Z, Katsaounou P, Doukas G, Klimopoulos S, Roussos C, Zakynthinos S. Contribution of pain to inspiratory muscle dysfunction after upper abdominal surgery: A randomized controlled trial. Am J Respir Crit Care Med. 2000 Apr;161(4 Pt 1):1372-5. doi: 10.1164/ajrccm.161.4.9907082.
Background: PubMed 20608558Pelosi P, Gregoretti C. Perioperative management of obese patients. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):211-25. doi: 10.1016/j.bpa.2010.02.001.
Background: PubMed 11573670Loadsman JA, Hillman DR. Anaesthesia and sleep apnoea. Br J Anaesth. 2001 Feb;86(2):254-66. doi: 10.1093/bja/86.2.254.
Background: PubMed 22833138Cullen A, Ferguson A. Perioperative management of the severely obese patient: a selective pathophysiological review. Can J Anaesth. 2012 Oct;59(10):974-96. doi: 10.1007/s12630-012-9760-2. Epub 2012 Jul 26.
Background: PubMed 15809132Casati A, Putzu M. Anesthesia in the obese patient: pharmacokinetic considerations. J Clin Anesth. 2005 Mar;17(2):134-45. doi: 10.1016/j.jclinane.2004.01.009.
Publication of Study ResultsLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Konstantinos Louis, MD, PhD study director

Dpt of ObGyn, Konstantopoulio-Patision Hospital, Greece

Konstantinos Roditis, MD, MSc study chair

Dpt of Vascular Surgery, Korgialenio-Benakio HRC Hospital, Greece

Aikaterini N. Alexandropoulou, MD, PhD principal investigator

Anaesthesiology Dpt, Evangelismos Hospital, Greece

Questions about this trial

What is this clinical trial studying?

A study testing Bi-PAP in people with Atelectasis and Pulmonary Infection, run by Evangelismos Hospital.

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 5 inclusion and 3 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 16 Dec 2020. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Forced Expiratory Volume at One Second (FEV1) Difference (time frame: 24 h before surgery and at 24, 48 and 72 h post-operatively). The study lists 6 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 NCT03438383, which also lists 40 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 16 Dec 2020.