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ObesityNCT02503241

Open Lung Strategy in Critically Ill Morbid Obese Patients

A study testing PEEP INCREMENTAL and PEEP DECREMENTAL in people with Obesity and Respiratory Insufficiency, run by Massachusetts General Hospital at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this interventional crossover study in morbidly obese intubated and mechanically ventilated patients is to describe the respiratory mechanics and the heart-lung interaction at titrated positive end-expiratory pressure levels following a recruitment maneuver with transthoracic echocardiography and electric… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PEEP INCREMENTAL and PEEP DECREMENTAL
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
Apr 2016to 30 Jun 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ICU admitted requiring intubation and mechanical ventilation
  • BMI ≥ 35 kg/m2
  • Waist circumference > 88 cm (for women)
  • Waist circumference > 102 cm (for men)

Who cannot join

  • Known presence of esophageal varices
  • Recent esophageal trauma or surgery
  • Severe thrombocytopenia (Platelets count ≤ 5,000/mm3)
  • Severe coagulopathy (INR ≥ 4)
  • Presence or history of pneumothorax
  • Pregnancy
Show all 9Show fewer
  • Patients with poor oxygenation index (PaO2/FiO2< 100 mmHg with at least 10 cmH2O of PEEP)
  • Pacemaker and/or internal cardiac defibrillator
  • Hemodynamic parameters: systolic blood pressure (SBP) <100 mmHg and >180 mmHg, or if SBP is between 100-180 mmHg on high dose of IV continuous infusion norepinephrine (>20 μg per minute), or dobutamine (>10 μg per minute), or dopamine (>10 μg per Kg per minute), or epinephrine (>10 μg per minute).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Open Lung Strategy in Critically Ill Morbid Obese Patients Lung Imaging and Heart-lung Interaction

The goal of this interventional crossover study in morbidly obese intubated and mechanically ventilated patients is to describe the respiratory mechanics and the heart-lung interaction at titrated positive end-expiratory pressure levels following a recruitment maneuver with transthoracic echocardiography and electric impedance tomography imaging.

Read the detailed description

Obese patients under mechanical ventilation are more likely to develop atelectasis as a consequence of the increased abdominal weight. Atelectasis is the primary responsible for respiratory insufficiency and impossibility to wean obese patients from respiratory support.

In a previous study we demonstrated the efficacy of the application of titrated PEEP levels following a recruitment maneuver in obese patients, i.e. improvement in respiratory mechanics and gas exchanges without negative hemodynamic effects.

The application of lung and heat imaging will allow us to quantitatively describe:

  • Increase in aerated lung tissue (reduction of atelectasis)
  • Reduction of over-inflation of the ventilated regions
  • Recoupling of ventilation and perfusion
  • Improvement in right heart function by reduction of right heart afterload
Being tested
PEEP INCREMENTAL, PEEP DECREMENTAL
Medical subject headings
Obesity, Respiratory Insufficiency, Heart Failure, Pulmonary Atelectasis

What participants receive

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

  • PEEP INCREMENTALProcedure or surgery

    Also called PEEP_Titration

    PEEP was progressively increased by steps of 2 cmH2O every 60 second until the end-expiratory transpulmonary pressure became positive between 0-2 cmH2O.

  • PEEP DECREMENTALProcedure or surgery

    Also called PEEP_Titration

    Lung recruitment maneuver (LRM) is a transitory and controlled increase in airway pressure to open collapsed alveoli. LRM is the first step of the PEEP DECREMENTAL method. After LRM, PEEP is systematically decreased, in small decrements, until the best respiratory system mechanics is identified.

Study groups in NCT02503241
Study groupRoleWhat they receive
PEEP_Titration_INCREMENTALExperimentalThe investigators will compare 3 levels of PEEP (BASELINE versus PEEP INCREMENTAL versus PEEP DECREMENTAL). Baseline PEEP is based in the standard of care PEEP used in the participant units. PEEP incremental value is based in transpulmonary pressure. Intervention : PEEP INCREMENTAL
Receives: Procedure: PEEP INCREMENTAL; Procedure: PEEP DECREMENTAL
PEEP_Titration_DECREMENTALExperimentalThe investigators will compare 3 levels of PEEP (BASELINE versus PEEP INCREMENTAL versus PEEP DECREMENTAL). Baseline PEEP is based in the standard of care PEEP used in the participant units. PEEP decremental value is based in lung recruitment maneuver followed by a best compliance curve during PEEP decrements. Intervention :PEEP DECREMENTAL
Receives: Procedure: PEEP INCREMENTAL; Procedure: PEEP DECREMENTAL

What is being measured

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

  1. Respiratory System Elastance

    Difference in Respiratory System Elastance measured in cmH2O/L

    Measured: During study time points :baseline, PEEP incremental, PEEP decremental

Secondary outcomes (3)

  1. Lung mechanics - Compliance

    Difference in respiratory system, lung and chest wall compliance measured in mL/cmH2O

    Measured: Study time points: baseline, PEEP incremental, PEEP decremental

  2. Lung mechanics - Airway resistances

    Difference in resistances of the airways measured as cmH2O/L/sec (Raw)

    Measured: During study time points: baseline, PEEP incremental, PEEP decremental

  3. Survival

    Incidence of death among the study population

    Measured: 28 days after the performance of the study protocol

Timeline

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

  1. First posted20 Jul 2015 (estimated)
  2. Study startApr 2016
  3. Primary completion30 Jun 2021 (estimated)
  4. Study completion30 Jun 2022 (estimated)

Resources

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
Non-randomised
Intervention model
Crossover
Model description
Physiologic crossover study. There is no randomization. All participants will receive the same interventions in the same order.
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02503241
Sponsor's protocol ID
PRICESEOBESE
Status last verified
Nov 2020
First submitted
17 Jul 2015
Last updated
17 Nov 2020
Results posted
No
Data monitoring committee
No

Publications

  • Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.

    PubMed 24467647

  • Behazin N, Jones SB, Cohen RI, Loring SH. Respiratory restriction and elevated pleural and esophageal pressures in morbid obesity. J Appl Physiol (1985). 2010 Jan;108(1):212-8. doi: 10.1152/japplphysiol.91356.2008. Epub 2009 Nov 12.

    PubMed 19910329

  • Borges JB, Suarez-Sipmann F, Bohm SH, Tusman G, Melo A, Maripuu E, Sandstrom M, Park M, Costa EL, Hedenstierna G, Amato M. Regional lung perfusion estimated by electrical impedance tomography in a piglet model of lung collapse. J Appl Physiol (1985). 2012 Jan;112(1):225-36. doi: 10.1152/japplphysiol.01090.2010. Epub 2011 Sep 29.

    PubMed 21960654

  • 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

  • Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23.

    PubMed 14693669

  • Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.

    PubMed 19186406

  • Krishnan S, Schmidt GA. Acute right ventricular dysfunction: real-time management with echocardiography. Chest. 2015 Mar;147(3):835-846. doi: 10.1378/chest.14-1335.

    PubMed 25732449

  • Vieillard-Baron A, Jardin F. Why protect the right ventricle in patients with acute respiratory distress syndrome? Curr Opin Crit Care. 2003 Feb;9(1):15-21. doi: 10.1097/00075198-200302000-00004.

    PubMed 12548024

  • De Santis Santiago R, Teggia Droghi M, Fumagalli J, Marrazzo F, Florio G, Grassi LG, Gomes S, Morais CCA, Ramos OPS, Bottiroli M, Pinciroli R, Imber DA, Bagchi A, Shelton K, Sonny A, Bittner EA, Amato MBP, Kacmarek RM, Berra L; Lung Rescue Team Investigators. High Pleural Pressure Prevents Alveolar Overdistension and Hemodynamic Collapse in Acute Respiratory Distress Syndrome with Class III Obesity. A Clinical Trial. Am J Respir Crit Care Med. 2021 Mar 1;203(5):575-584. doi: 10.1164/rccm.201909-1687OC.

    PubMed 32876469

Questions about this trial

What is this clinical trial studying?

A study testing PEEP INCREMENTAL and PEEP DECREMENTAL in people with Obesity and Respiratory Insufficiency, run by Massachusetts General Hospital at 1 site in United States.

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 9 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: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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?

Respiratory System Elastance (time frame: During study time points :baseline, PEEP incremental, PEEP decremental). 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 NCT02503241, which also lists 9 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 17 Nov 2020.

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