Expired Study
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Boston, Massachusetts 02114


Purpose:

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.


Study summary:

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


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 at screening (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).


NCT ID:

NCT02503241


Primary Contact:

Principal Investigator
Robert Kacmarek, RRT, PhD
Massachusetts General Hospital


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02114
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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