Clinical Trial: Open Lung Strategy in Critically Ill Morbid Obese Patients
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Open Lung Strategy in Critically Ill Morbid Obese Patients Lung Imaging and Heart-lung Interaction
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 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
Sponsor: Massachusetts General Hospital
Current Primary Outcome: Lung elastance [ Time Frame: intraoperative ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Lung mechanics - Compliance [ Time Frame: intraoperative ]Difference in respiratory system, lung and chest wall compliance measured in mL/cmH2O
- Lung mechanics - Airway resistances [ Time Frame: intraoperative ]Difference in resistances of the airways measured as cmH2O/L/sec (Raw)
- Lung imaging - Lung collapse and lung over-distention [ Time Frame: intraoperative ]Percentage of lung tissue collapsed and/or over-distended at different PEEP levels. Both collapse and over distention are measured as decrease in regional compliance measured through electrical impedance tomography
- Lung imaging - Electrical impedance tomography ventilation data [ Time Frame: intraoperative ]Difference in aeration (end expiratory lung impedance) and in distribution of ventilation (regional compliance) measured as difference in global an regional electrical impedance distribution
- Hemodynamics - Blood pressure [ Time Frame: intraoperative ]Changes in invasive arterial blood pressures (BP, mmHg)
- Hemodynamics - Heart rate [ Time Frame: intraoperative ]Changes in heart rate (HR, bpm)
- Hemodynamics - Central venous pressure [ Time Frame: intraoperative ]Changes in central venous pressure (CVP, mmHg)
- Intra-abdominal pressure [ Time Frame: intraoperative ]Changes in bladder pressure measured in mmHg
- Gas Exchange - Oxygenation [ Time Frame: Baseline (PEEP 10 cmH2O), at titrated PEEP level, at titrated PEEP level after a recruitment maneuver and 24 hours after the performance of the study protocol ]Difference in oxygenation measured in mmHg of PaO2/FiO2
- Gas Exchange - Arterial carbon dioxide [ Time Frame: Baseline (PEEP 10 cmH2O), at titrated PEEP level, at titrated PEEP level after a recruitment maneuver and 24 hours after the performance of the study protocol ]Difference in arterial carbon dioxide measured in mmHg (PaCO2)
- Lung volumes - respiratory dead space [ Time Frame: Baseline (PEEP 10 cmH2O), at titrated PEEP level and at titrated PEEP level after a recruitment maneuver ]Difference in dead space fraction measured as the ratio of death volume over the total tidal volume (Vd/Vt)
- Lung imaging - Electrical impedance tomography perfusion data [ Time Frame: Baseline (PEEP 10 cmH2O) and at titrated PEEP level after a recruitment maneuver ]Differences in distribution in lung perfusion measured as regional percentage of the total cardiac output
- Right heart function - TAPSE [ Time Frame: Baseline (PEEP 10 cmH2O), at titrated PEEP level and at titrated PEEP level after a recruitment maneuver ]Differences in Tricuspid Annular Plane Systolic Excursion measured through two-dimensional transthoracic echocardiography (apical four-chamber view)
- Right heart function - S' [ Time Frame: Baseline (PEEP 10 cmH2O), at titrated PEEP level and at titrated PEEP level after a recruitment maneuver ]Differences in the systolic excursion of the tricuspid annulus measured by tissue doppler imaging
- Right heart function - Tei index [ Time Frame: Baseline (PEEP 10 cmH2O), at titrated PEEP level and at titrated PEEP level after a recruitment maneuver ]Differences in global right ventricular function obtained from right ventricle tissue doppler imaging
- Hemodynamics [ Time Frame: 24 hours after the performance of the study protocol ]Arterial blood pressure, urinary output, water balance, requirement for vasopressors, serum creatinine will be collected
- Duration of mechanical ventilation [ Time Frame: 30 days after the performance of the study protocol ]Number of days on mechanical ventilation
- ICU and hospital length of stay [ Time Frame: 30 days after the performance of the study protocol ]Numbers of days spent in the intensive care unit and numbers of days of in-hospital care
- Incidence of tracheostomy [ Time Frame: 30 days after the performance of the study protocol ]Necessity of tracheostomy for prolonged ventilatory support among the study population
- Survival [ Time Frame: 30 days after the performance
Original Secondary Outcome: Same as current
Information By: Massachusetts General Hospital
Dates:
Date Received: July 17, 2015
Date Started: April 2016
Date Completion: December 2018
Last Updated: February 8, 2017
Last Verified: February 2017