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NCT06675435Not yet recruiting

Inhaled Nitric Oxide in Severe Obesity

The Effect of Inhaled Nitric Oxide on Intrapulmonary Shunt in Acutely Hypoxemic Patients With Severe Obesity

Source: ClinicalTrials.gov · Last updated 20 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
4 Nov 2024
Start date
Oct 2026
Primary completion date
Oct 2028
Lead sponsor
Massachusetts General Hospital
Diseases
Obesity
NCT number
NCT06675435

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From Oct 2026 to the primary completion date, Oct 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of inhaled or oral pulmonary vasodilatory therapy within the 24 hours preceding study enrollment
  • 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 over the past two hours just before enrollment: more than 15 mcg/min for norepinephrine and dopamine, more than 10 mcg/min in epinephrine; and more than 50 mcg/ min for phenylephrine.
    • EIT assessments of lung perfusion will only be performed in participants who are already receiving neuromuscular blocking agents (e.g., cisatracurium) at the time of study enrollment. EIT assessments of lung perfusion will not be performed in participants who have the following contraindications to EIT perfusion monitoring:

Other illness

  • Chronic pulmonary vascular disease on home chemical vasodilator support (e.g., sildenafil)
  • History of lung resection or transplant
  • Usage of any devices with electric current generation such as pacemaker or internal cardiac defibrillator
    • For controls without acute hypoxemic respiratory failure

Lab values

  • 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
  • Hypernatremia (serum sodium \> 150 mEq/L)

Age

  • Age \< 18 years
  • Age \< 18 years

Other

  • Pregnancy or known active breastfeeding
  • Prisoner or Incarceration
  • Inability or unwillingness of subject or legal surrogate/representative to give written informed consent
  • 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
  • Pregnancy or known active breastfeeding
  • Prisoner or Incarceration
  • Inability or unwillingness of subject or legal surrogate/representative to give written informed consent

Who the study is looking for

  • 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
  • Receiving invasive mechanical ventilation and do not have a diagnosis of acute hypoxemic respiratory failure (PaO2/FiO2 \> 300 mmHg or SpO2/FiO2\> 315)
  • Presence of an arterial catheter
  • Admitted to a participating MGH ICU

Criteria the registry did not label

  • For participants with acute hypoxemic respiratory failure

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Massachusetts General Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.