Open Lung Strategy in Critically Ill Morbid Obese Patients

Not Applicable

• Conditions: Respiratory Mechanics; Obesity; Respiratory Insufficiency; Right-Sided Heart Failure; Pulmonary Atelectasis
• Interventions: Procedure: PEEP INCREMENTAL; Procedure: PEEP DECREMENTAL

• 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

Arm && Interventions

Group	Intervention	Description
PEEP_Titration_INCREMENTAL	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 incremental value is based in transpulmonary pressure. Intervention : PEEP INCREMENTAL
PEEP_Titration_DECREMENTAL	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
PEEP_Titration_INCREMENTAL	PEEP 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 incremental value is based in transpulmonary pressure. Intervention : PEEP INCREMENTAL
PEEP_Titration_DECREMENTAL	PEEP 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

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