Inhaled Nitric Oxide in Severe Obesity (NCT06675435) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Inhaled Nitric Oxide in Severe Obesity
United States60 participantsStarted 2026-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 inhaled or oral pulmonary vasodilatory therapy within the 24 hours preceding study enrollment
* Contraindication to inhaled NO
* Baseline Methemoglobin ≥ 3%
* Known left ventricle ejection fraction \< 20%
* Known history of G6PD deficiency or cytochrome issues
* Prior adverse reaction to inhaled nitric oxide
* Presence of pneumothorax or acute pulmonary embolism
* Chronic hypoxemia requiring home supplemental non-invasive oxygen (nasal cannula or positive pressure ventilation) or home mechanical ventilation
* Chronic pulmonary vascular disease on home chemical vasodilator support (e.g., sildenafil)
* History of lung resection or transplant
* Hemodynamic instability at the time of potential study enrollment defined as:
* Persistent systolic blood pressure \< 90 mmHg or \>180 mmHg despite the use of vasopressor or vasodilators or
* Requiring an increment in inotropic-vasopressors o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intrapulmonary shunt
Timeframe: Intrapulmonary shunt will be assessed before inhaled nitric oxide, at 15 minutes after inhaled nitric oxide, and at 15 minutes after inhaled nitric oxide discontinuation.