← Back to Search

Vasodilator

Inhaled Nitric Oxide for Respiratory Failure in Obesity

N/A
Waitlist Available
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Controls without acute hypoxemic respiratory failure must be on invasive mechanical ventilation
Controls without acute hypoxemic respiratory failure must have an arterial catheter
Must not have
Patients with acute hypoxemic respiratory failure must not have a known left ventricle ejection fraction less than 20%
Patients with acute hypoxemic respiratory failure must not have preexisting chronic lung disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up right ventricular systolic pressure will be assessed before inhaled nitric oxide, at 15 minutes after inhaled nitric oxide, and at 15 minutes after inhaled nitric oxide discontinuation.
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to understand how inhaled nitric oxide affects oxygen levels and lung function in severely obese patients with acute respiratory failure. It will compare these effects in obese patients to those with normal body weight

Who is the study for?
This trial is for patients with severe obesity who are experiencing acute hypoxemic respiratory failure and require mechanical ventilation. Specific eligibility criteria details are not provided, but typically participants would need to meet certain health conditions.
What is being tested?
The study tests the effects of inhaled nitric oxide on oxygen levels, lung blood flow, and heart function in severely obese patients with low oxygen levels due to respiratory failure compared to those with normal weight.
What are the potential side effects?
While specific side effects are not listed, inhaled nitric oxide can sometimes cause headaches, dizziness, or increased risk of bleeding. It may also affect lung function or interact with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on a breathing machine and do not have sudden low oxygen levels.
Select...
I have an arterial catheter and do not have acute low oxygen levels in my blood.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My heart pumps blood well despite my severe lung issue.
Select...
I have acute breathing problems but no chronic lung disease.
Select...
I am not pregnant, suspected to be pregnant, or less than six weeks postpartum and have severe breathing issues.
Select...
My Methemoglobin level is below 3%.
Select...
I am not using inhaled medication for severe breathing problems.
Select...
I do not have a collapsed lung along with my breathing issue.
Select...
My sodium levels are not above 150 mEq/L.
Select...
I have never had lung cancer, a lung removal, or a lung transplant.
Select...
My blood pressure is stable and I don't need increasing amounts of medicine to maintain it.
Select...
I do not use a pacemaker or internal defibrillator.
Select...
I am 18 or older and do not have severe breathing problems due to low oxygen.
Select...
I do not have chronic lung disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Intrapulmonary shunt
Secondary study objectives
Gas exchange
Regional pulmonary perfusion
Right ventricular systolic pressure
Other study objectives
Nitric oxide activity
Nitric oxide signaling pathways

Side effects data

From 2015 Phase 3 trial • 800 Patients • NCT00551642
48%
Anaemia
46%
Patent ductus arteriosus
31%
Hyperbilirubinaemia
25%
Jaundice
23%
Hyperglycaemia
18%
Apnoea
18%
Haemorrhage intracranial
17%
Sepsis
14%
Hypotension
12%
Metabolic acidosis
7%
Thrombocytopenia
5%
Hyponatraemia
4%
Necrotising enterocolitis neonatal
4%
Intestinal perforation
3%
Pneumothorax
3%
Pulmonary haemorrhage
2%
Periventricular leukomalacia
1%
Hypoxia
1%
Cardiac arrest
1%
Persistent foetal circulation
1%
Gastrointestinal perforation
1%
Hydrocephalus
1%
Neonatal respiratory failure
1%
Pulmonary hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Inhaled Nitric Oxide (INO)
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Acute hypoxemic respiratory failureExperimental Treatment1 Intervention
Participants (n = 40) with acute hypoxemic respiratory failure will receive inhaled nitric oxide (20 ppm) for 15 min.
Group II: Participants without acute hypoxemic respiratory failureActive Control1 Intervention
Participants (n = 20) without acute hypoxemic respiratory failure will not receive inhaled nitric oxide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitric oxide
2005
Completed Phase 3
~860

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,729 Total Patients Enrolled
74 Trials studying Obesity
292,474 Patients Enrolled for Obesity
~40 spots leftby Oct 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top