Open Lung Strategy in Critically Ill Morbid Obese Patients

Massachusetts General Hospital21 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity Respiratory Insufficiency Right-Sided Heart Failure Pulmonary Atelectasis Respiratory Mechanics

Interventions

PEEP INCREMENTALPROCEDURE

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

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Respiratory System Elastance

Difference in Respiratory System Elastance measured in cmH2O/L

Time frame: During study time points :baseline, PEEP incremental, PEEP decremental

Secondary Outcomes

Lung mechanics - Compliance

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

Time frame: Study time points: baseline, PEEP incremental, PEEP decremental

Lung mechanics - Airway resistances

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

Time frame: During study time points: baseline, PEEP incremental, PEEP decremental

Survival

Incidence of death among the study population

Time frame: 28 days after the performance of the study protocol

Data from ClinicalTrials.gov

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