The Effect of Inhaled Nitric Oxide on Intrapulmonary Shunt in Acutely Hypoxemic Patients With Severe Obesity
Massachusetts General Hospital
Summary
The goal of this clinical trial is to learn about the effects of inhaled nitric oxide on oxygenation and lung perfusion in participants with severe obesity who have acute hypoxemic respiratory failure and are on mechanical ventilation The main questions it aims to answer are: 1. In acute hypoxemic respiratory failure, what are the effects of inhaled nitric oxide on oxygenation in participants with severe obesity compared to participants with normal body weight. 2. In acute hypoxemic respiratory failure, what are the effects of inhaled nitric oxide on lung perfusion and heart function in participants with severe obesity compared to participants with normal body weight. 3. In acute hypoxemic respiratory failure, does severe obesity impact nitric oxide signaling pathways? Participants with acute hypoxemic respiratory failure will be exposed to inhaled nitric oxide (20 ppm) while being clinically monitored.
Description
The study is a single-center, open-label clinical trial in mechanically ventilated participants with acute hypoxemic respiratory failure. The primary aim is to assess changes in intrapulmonary shunt (primary study outcome) to inhaled nitric oxide in participants with severe obesity and those with normal body weight. The secondary aims are to determine differences in regional lung perfusion (measured by electrical impedance tomography), right ventricular pressure (measured by transthoracic echocardiography), and biomarkers of nitric oxide signaling dysfunction (nitric oxide activity, pro-inflam…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
For participants with acute hypoxemic respiratory failure Inclusion Criteria: * Acute hypoxemic respiratory failure, defined as persistent hypoxemia (PaO2/FiO2 ≤ 300 mmHg or SpO2/FiO2 ≤ 315) and on invasive mechanical ventilation for \< 72 hours * Presence of an arterial and central venous catheter (for blood gas measurement) * Admitted to a participating MGH ICU Exclusion Criteria: * Age \< 18 years * Pregnancy or known active breastfeeding * Prisoner or Incarceration * Inability or unwillingness of subject or legal surrogate/representative to give written informed consent * Use of inhale…
Interventions
- DeviceNitric oxide
20ppm for 15 minutes delivered by INO max(Nitric Oxide) Company : INO therapeutics, Inc.
Location
- Massachusetts General HospitalBoston, Massachusetts