Clinical trial NCT02503241: Open Lung Strategy in Critically Ill Morbid Obese Patients
Official title: Open Lung Strategy in Critically Ill Morbid Obese Patients Lung Imaging and Heart-lung Interaction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Respiratory Insufficiency
Right-Sided Heart Failure
Pulmonary Atelectasis
Respiratory Mechanics
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Physiologic crossover study. There is no randomization. All participants will receive the same interventions in the same order.
Primary purpose: TREATMENT

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

Eligibility 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 (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).

Primary outcomes:
measure: Respiratory System Elastance
timeFrame: During study time points :baseline, PEEP incremental, PEEP decremental
Secondary outcomes:
measure: Lung mechanics - Compliance
timeFrame: Study time points: baseline, PEEP incremental, PEEP decremental
measure: Lung mechanics - Airway resistances
timeFrame: During study time points: baseline, PEEP incremental, PEEP decremental
measure: Survival
timeFrame: 28 days after the performance of the study protocol
Other outcomes:
measure: Intra-abdominal pressure
timeFrame: Study time point: baseline
measure: Electrical Impedance Tomography measurement: collapsed and overdistension
timeFrame: Study time points: baseline, PEEP incremental, PEEP decremental
measure: Electrical Impedance Tomography measurement: distribution of ventilation
timeFrame: Study time points: baseline, PEEP incremental, PEEP decremental
measure: Electrical Impedance Tomography measurement: lung perfusion
timeFrame: Study time points: baseline, PEEP incremental, PEEP decremental
measure: Central venous pressure
timeFrame: Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
measure: Gas Exchange - Oxygenation
timeFrame: Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
measure: Gas Exchange - Arterial carbon dioxide
timeFrame: Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
measure: Lung volumes - respiratory dead space
timeFrame: Study time points: baseline, PEEP incremental, PEEP decremental.
measure: Heart rate
timeFrame: Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
measure: Blood pressure
timeFrame: A) 48 and 24h before study procedures B)Study time points: baseline, PEEP incremental, PEEP decremental C)Follow up: 1, 2 , 24, 48 and 72 hours after study procedures.
measure: Right heart function -Tricuspid Annular Plane Systolic Excursion (TAPSE)
timeFrame: Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
measure: Right heart function - S'
timeFrame: Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures
measure: Right heart function - Tei index
timeFrame: Study time points: baseline, PEEP incremental, PEEP decremental
measure: Vasopressor requirement
timeFrame: 48, 24h before AND 24, 48 and 72h after study procedures.
measure: Creatinine
timeFrame: 48, 24h before AND 24, 48 and 72h after study procedures.
measure: Urinary output
timeFrame: 48, 24h before AND 24, 48 and 72h after study procedures.
measure: Fluid balance
timeFrame: 48, 24h before AND 24, 48 and 72h after study procedures.
measure: Incidence of tracheostomy
timeFrame: 28 days after the performance of the study protocol
measure: Duration of mechanical ventilation
timeFrame: 28 days after the performance of the study protocol
measure: Intensive care unit length of stay
timeFrame: 28 days after the performance of the study protocol
measure: Hospital length of stay
timeFrame: 28 days after the performance of the study protocol
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Robert Kacmarek, RRT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Lorenzo Berra, MD
role: PRINCIPAL_INVESTIGATOR
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