Open Lung Strategy in Critically Ill Morbid Obese Patients

Not Applicable

• Conditions: Respiratory Mechanics; Obesity; Respiratory Insufficiency; Right-Sided Heart Failure; Pulmonary Atelectasis

• Registration Number: NCT02503241
• Lead Sponsor: Massachusetts General Hospital

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

Study Timeline

• Study First Submitted: 2015-07-17
• Study First Submitted QC: 2015-07-17
• Study First Posted: 2015-07-20
• Study Start: 2016-04
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-17
• Primary Completion: 2021-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Respiratory System Elastance	During study time points :baseline, PEEP incremental, PEEP decremental	Difference in Respiratory System Elastance measured in cmH2O/L

Secondary Outcome Measures

Name	Time	Method
Lung mechanics - Compliance	Study time points: baseline, PEEP incremental, PEEP decremental	Difference in respiratory system, lung and chest wall compliance measured in mL/cmH2O
Lung mechanics - Airway resistances	During study time points: baseline, PEEP incremental, PEEP decremental	Difference in resistances of the airways measured as cmH2O/L/sec (Raw)
Survival	28 days after the performance of the study protocol	Incidence of death among the study population

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States