Back to search results

Inhaled Nitric Oxide for Severe Obesity and Respiratory Failure

This study is looking at how inhaled nitric oxide affects people with severe obesity who have acute hypoxemic respiratory failure (a sudden, severe lack of oxygen in the blood) and are on a breathing machine. Researchers want to see if inhaled nitric oxide improves oxygen levels and blood flow in the lungs. They will compare the effects in people with severe obesity to those with a normal weight. The main goal is to measure changes in "intrapulmonary shunt" (blood flowing through the lungs without picking up oxygen) after receiving 20 parts per million of nitric oxide for 15 minutes. The study is currently unclear on its recruitment status and plans to enroll 60 participants.

Study design
This is a single-center, open-label study involving 60 participants who are on mechanical ventilation. It compares the effects of inhaled nitric oxide in people with severe obesity to those with normal body weight.
What's involved
You would receive inhaled nitric oxide for 15 minutes. Measurements of intrapulmonary shunt would be taken before, during, and after this treatment. You would also need an arterial and central venous catheter for blood gas measurements.
Compensation
Not stated in the trial record.
Follow-up
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.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06675435

Inhaled Nitric Oxide in Severe Obesity

Not Yet Recruiting
NAAges 18+InterventionalDiagnostic
Massachusetts General Hospital
~60 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Nitric oxide

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intrapulmonary shunt
Measured over 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.

Conditions

Obesity
Respiratory Insufficiency
Hypoxemic Respiratory Failure
Nitric Oxide

Explore related trials

Hypoxemic respiratory failureObesity

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Timothy Gaulton, MD, MSc
[email protected]
6177263030
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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 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.
Hypernatremia (serum sodium \> 150 mEq/L)
Usage of any devices with electric current generation such as pacemaker or internal cardiac defibrillator
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

What this trial measures

  • Intrapulmonary shuntIntrapulmonary shunt will be assessed before inhaled nitric oxide, at 15 minutes after inhaled nitric oxide, and at 15 minutes after inhaled nitric oxide discontinuation.

    Intrapulmonary shunt will be defined as the difference in intrapulmonary shunt (%) to inhaled nitric oxide. Intrapulmonary shunt will be defined using the modified Berggren equation based on central venous and arterial oxygen concentrations from a central venous and peripheral arterial catheter.