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Open Lung Strategy in Critically Ill Morbid Obese Patients

Primary Purpose

Obesity, Respiratory Insufficiency, Right-Sided Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEEP INCREMENTAL
PEEP DECREMENTAL
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PEEP_Titration_INCREMENTAL

PEEP_Titration_DECREMENTAL

Arm Description

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

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

Outcomes

Primary Outcome Measures

Respiratory System Elastance
Difference in Respiratory System Elastance measured in cmH2O/L

Secondary Outcome Measures

Lung mechanics - Compliance
Difference in respiratory system, lung and chest wall compliance measured in mL/cmH2O
Lung mechanics - Airway resistances
Difference in resistances of the airways measured as cmH2O/L/sec (Raw)
Survival
Incidence of death among the study population

Full Information

First Posted
July 17, 2015
Last Updated
November 16, 2020
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02503241
Brief Title
Open Lung Strategy in Critically Ill Morbid Obese Patients
Official Title
Open Lung Strategy in Critically Ill Morbid Obese Patients Lung Imaging and Heart-lung Interaction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 impedance tomography imaging.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Respiratory Insufficiency, Right-Sided Heart Failure, Pulmonary Atelectasis, Respiratory Mechanics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Physiologic crossover study. There is no randomization. All participants will receive the same interventions in the same order.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEEP_Titration_INCREMENTAL
Arm Type
Experimental
Arm Description
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
Arm Title
PEEP_Titration_DECREMENTAL
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
PEEP INCREMENTAL
Other Intervention Name(s)
PEEP_Titration
Intervention Description
PEEP was progressively increased by steps of 2 cmH2O every 60 second until the end-expiratory transpulmonary pressure became positive between 0-2 cmH2O.
Intervention Type
Procedure
Intervention Name(s)
PEEP DECREMENTAL
Other Intervention Name(s)
PEEP_Titration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory System Elastance
Description
Difference in Respiratory System Elastance measured in cmH2O/L
Time Frame
During study time points :baseline, PEEP incremental, PEEP decremental
Secondary Outcome Measure Information:
Title
Lung mechanics - Compliance
Description
Difference in respiratory system, lung and chest wall compliance measured in mL/cmH2O
Time Frame
Study time points: baseline, PEEP incremental, PEEP decremental
Title
Lung mechanics - Airway resistances
Description
Difference in resistances of the airways measured as cmH2O/L/sec (Raw)
Time Frame
During study time points: baseline, PEEP incremental, PEEP decremental
Title
Survival
Description
Incidence of death among the study population
Time Frame
28 days after the performance of the study protocol
Other Pre-specified Outcome Measures:
Title
Intra-abdominal pressure
Description
Changes in bladder pressure measured in mmHg.
Time Frame
Study time point: baseline
Title
Electrical Impedance Tomography measurement: collapsed and overdistension
Description
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).
Time Frame
Study time points: baseline, PEEP incremental, PEEP decremental
Title
Electrical Impedance Tomography measurement: distribution of ventilation
Description
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).
Time Frame
Study time points: baseline, PEEP incremental, PEEP decremental
Title
Electrical Impedance Tomography measurement: lung perfusion
Description
Differences in distribution in lung perfusion measured as regional percentage of the total cardiac output.
Time Frame
Study time points: baseline, PEEP incremental, PEEP decremental
Title
Central venous pressure
Description
Changes in central venous pressure (CVP, mmHg)
Time Frame
Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Title
Gas Exchange - Oxygenation
Description
Difference in oxygenation measured in mmHg of PaO2/FiO2
Time Frame
Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Title
Gas Exchange - Arterial carbon dioxide
Description
Difference in arterial carbon dioxide measured in mmHg (PaCO2)
Time Frame
Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Title
Lung volumes - respiratory dead space
Description
Difference in dead space fraction measured as the ratio of death volume over the total tidal volume (Vd/Vt)
Time Frame
Study time points: baseline, PEEP incremental, PEEP decremental.
Title
Heart rate
Description
Changes in heart rate (HR, bpm)
Time Frame
Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Title
Blood pressure
Description
Changes in invasive arterial blood pressures (BP, mmHg)
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.
Title
Right heart function -Tricuspid Annular Plane Systolic Excursion (TAPSE)
Description
Differences in TAPSE measured through two-dimensional transthoracic echocardiography (apical four-chamber view).
Time Frame
Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Title
Right heart function - S'
Description
Differences in the systolic excursion of the tricuspid annulus measured by tissue doppler imaging.
Time Frame
Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
Title
Right heart function - Tei index
Description
Differences in global right ventricular function obtained from right ventricle tissue doppler imaging.
Time Frame
Study time points: baseline, PEEP incremental, PEEP decremental
Title
Vasopressor requirement
Description
Norepinephrine (mcg/kg/min), epinephrine (mcg/kg/min) , phenylephrine ( mcg/kg/min) and vasopressin (U / min)
Time Frame
48, 24h before AND 24, 48 and 72h after study procedures.
Title
Creatinine
Description
Serum level of creatinine
Time Frame
48, 24h before AND 24, 48 and 72h after study procedures.
Title
Urinary output
Description
Changes in urinary output (mL)
Time Frame
48, 24h before AND 24, 48 and 72h after study procedures.
Title
Fluid balance
Description
Changes in fluid balance (mL)
Time Frame
48, 24h before AND 24, 48 and 72h after study procedures.
Title
Incidence of tracheostomy
Description
Necessity of tracheostomy for prolonged ventilatory support among the study population
Time Frame
28 days after the performance of the study protocol
Title
Duration of mechanical ventilation
Description
Number of days on mechanical ventilation
Time Frame
28 days after the performance of the study protocol
Title
Intensive care unit length of stay
Description
Numbers of days spent in the intensive care
Time Frame
28 days after the performance of the study protocol
Title
Hospital length of stay
Description
Numbers of days spent in the hospital
Time Frame
28 days after the performance of the study protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Kacmarek, RRT, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lorenzo Berra, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Open Lung Strategy in Critically Ill Morbid Obese Patients

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