Open Lung Strategy in Critically Ill Morbid Obese Patients

November 16, 2020 updated by: Robert M. Kacmarek, Massachusetts General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PEEP_Titration_INCREMENTAL

The 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
Procedure: PEEP INCREMENTAL
PEEP was progressively increased by steps of 2 cmH2O every 60 second until the end-expiratory transpulmonary pressure became positive between 0-2 cmH2O.
Other Names:
  • PEEP_Titration
Procedure: PEEP DECREMENTAL
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.
Other Names:
  • PEEP_Titration
Experimental: PEEP_Titration_DECREMENTAL

The 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
Procedure: PEEP INCREMENTAL
PEEP was progressively increased by steps of 2 cmH2O every 60 second until the end-expiratory transpulmonary pressure became positive between 0-2 cmH2O.
Other Names:
  • PEEP_Titration
Procedure: PEEP DECREMENTAL
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.
Other Names:
  • PEEP_Titration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Respiratory System Elastance
Time Frame: During study time points :baseline, PEEP incremental, PEEP decremental
Difference in Respiratory System Elastance measured in cmH2O/L
During study time points :baseline, PEEP incremental, PEEP decremental

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lung mechanics - Compliance
Time Frame: Study time points: baseline, PEEP incremental, PEEP decremental
Difference in respiratory system, lung and chest wall compliance measured in mL/cmH2O
Study time points: baseline, PEEP incremental, PEEP decremental
Lung mechanics - Airway resistances
Time Frame: During study time points: baseline, PEEP incremental, PEEP decremental
Difference in resistances of the airways measured as cmH2O/L/sec (Raw)
During study time points: baseline, PEEP incremental, PEEP decremental
Survival
Time Frame: 28 days after the performance of the study protocol
Incidence of death among the study population
28 days after the performance of the study protocol

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intra-abdominal pressure
Time Frame: Study time point: baseline
Changes in bladder pressure measured in mmHg.
Study time point: baseline
Electrical Impedance Tomography measurement: collapsed and overdistension
Time Frame: Study time points: baseline, PEEP incremental, PEEP decremental
Percentage of lung tissue collapsed and over distended at different PEEP levels by analyzing pixel compliance ( variation in impedance divided by applied pressure during a respiratory cycle).
Study time points: baseline, PEEP incremental, PEEP decremental
Electrical Impedance Tomography measurement: distribution of ventilation
Time Frame: Study time points: baseline, PEEP incremental, PEEP decremental
Difference in end-expiratory lung impedance as percentage estimating the distribution of ventilation among 4 horizontal regions of interest ( from non-dependent to dependent lung regions).
Study time points: baseline, PEEP incremental, PEEP decremental
Electrical Impedance Tomography measurement: lung perfusion
Time Frame: Study time points: baseline, PEEP incremental, PEEP decremental
Differences in distribution in lung perfusion measured as regional percentage of the total cardiac output.
Study time points: baseline, PEEP incremental, PEEP decremental
Central venous pressure
Time Frame: Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Changes in central venous pressure (CVP, mmHg)
Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Gas Exchange - Oxygenation
Time Frame: Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Difference in oxygenation measured in mmHg of PaO2/FiO2
Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Gas Exchange - Arterial carbon dioxide
Time Frame: Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Difference in arterial carbon dioxide measured in mmHg (PaCO2)
Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Lung volumes - respiratory dead space
Time Frame: Study time points: baseline, PEEP incremental, PEEP decremental.
Difference in dead space fraction measured as the ratio of death volume over the total tidal volume (Vd/Vt)
Study time points: baseline, PEEP incremental, PEEP decremental.
Heart rate
Time Frame: Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Changes in heart rate (HR, bpm)
Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Blood pressure
Time Frame: A) 48 and 24h before study procedures B)Study time points: baseline, PEEP incremental, PEEP decremental C)Follow up: 1, 2 , 24, 48 and 72 hours after study procedures.
Changes in invasive arterial blood pressures (BP, mmHg)
A) 48 and 24h before study procedures B)Study time points: baseline, PEEP incremental, PEEP decremental C)Follow up: 1, 2 , 24, 48 and 72 hours after study procedures.
Right heart function -Tricuspid Annular Plane Systolic Excursion (TAPSE)
Time Frame: Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Differences in TAPSE measured through two-dimensional transthoracic echocardiography (apical four-chamber view).
Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Right heart function - S'
Time Frame: Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Differences in the systolic excursion of the tricuspid annulus measured by tissue doppler imaging.
Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Right heart function - Tei index
Time Frame: Study time points: baseline, PEEP incremental, PEEP decremental
Differences in global right ventricular function obtained from right ventricle tissue doppler imaging.
Study time points: baseline, PEEP incremental, PEEP decremental
Vasopressor requirement
Time Frame: 48, 24h before AND 24, 48 and 72h after study procedures.
Norepinephrine (mcg/kg/min), epinephrine (mcg/kg/min) , phenylephrine ( mcg/kg/min) and vasopressin (U / min)
48, 24h before AND 24, 48 and 72h after study procedures.
Creatinine
Time Frame: 48, 24h before AND 24, 48 and 72h after study procedures.
Serum level of creatinine
48, 24h before AND 24, 48 and 72h after study procedures.
Urinary output
Time Frame: 48, 24h before AND 24, 48 and 72h after study procedures.
Changes in urinary output (mL)
48, 24h before AND 24, 48 and 72h after study procedures.
Fluid balance
Time Frame: 48, 24h before AND 24, 48 and 72h after study procedures.
Changes in fluid balance (mL)
48, 24h before AND 24, 48 and 72h after study procedures.
Incidence of tracheostomy
Time Frame: 28 days after the performance of the study protocol
Necessity of tracheostomy for prolonged ventilatory support among the study population
28 days after the performance of the study protocol
Duration of mechanical ventilation
Time Frame: 28 days after the performance of the study protocol
Number of days on mechanical ventilation
28 days after the performance of the study protocol
Intensive care unit length of stay
Time Frame: 28 days after the performance of the study protocol
Numbers of days spent in the intensive care
28 days after the performance of the study protocol
Hospital length of stay
Time Frame: 28 days after the performance of the study protocol
Numbers of days spent in the hospital
28 days after the performance of the study protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRICESEOBESE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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