Can a simple gas help severely obese patients breathe better on ventilators?
NCT ID NCT06675435
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how inhaled nitric oxide affects oxygen levels and lung function in severely obese patients who have severe breathing failure and are on a ventilator. Researchers will compare these patients to those with normal weight to see if obesity changes how the gas works. The goal is to better understand how to treat this specific group.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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: * Hypernatremia (serum sodium \> 150 mEq/L) * Usage of any devices with electric current generation such as pacemaker or internal cardiac defibrillator For controls without acute hypoxemic respiratory failure Inclusion Criteria: * 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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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