Open Lung Strategy in Critically Ill Morbid Obese Patients

Mass General Brigham

Status: Unknown

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

Treatments: Procedure: PEEP INCREMENTAL; Procedure: PEEP DECREMENTAL

Study type: Interventional

Funder types: Other

Identifiers

NCT02503241

PRICESEOBESE

Details and patient eligibility

About

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.

Full 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

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

PEEP_Titration_INCREMENTAL

Experimental group

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

Treatment:

Procedure: PEEP DECREMENTAL

Procedure: PEEP INCREMENTAL

PEEP_Titration_DECREMENTAL

Experimental group

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

Treatment:

Procedure: PEEP DECREMENTAL

Procedure: PEEP INCREMENTAL