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Vasodilator
Nitric Oxide for Acute Respiratory Distress Syndrome
N/A
Recruiting
Led By Maurizio Cereda, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, arterial blood gas samples will be taken at two time points: before and 1 hour after ino. subsequent days up to 28 days will be determined by the critical care staff
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study a condition called Acute Respiratory Distress Syndrome (ARDS), where the lungs become inflamed due to various reasons like infection or trauma. Often, people with ARDS need
Who is the study for?
This trial is for adults over 18 who are in the ICU, intubated and on a ventilator due to mild to moderate ARDS. They must have an arterial line and central line already in place.
What is being tested?
The study tests if inhaling nitric oxide (iNO) improves blood flow in the lungs of ARDS patients using Electrical Impedance Tomography (EIT), compared with dual-energy computed tomography (DECT).
What are the potential side effects?
Inhaled nitric oxide may cause headaches, dizziness, or low blood pressure. It can also lead to airway inflammation or worsen lung function if not properly administered.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, arterial blood gas samples will be taken at two time points: before and 1 hour after ino. subsequent days up to 28 days will be determined by the critical care staff
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, arterial blood gas samples will be taken at two time points: before and 1 hour after ino. subsequent days up to 28 days will be determined by the critical care staff
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in regional lung perfusion after the delivery of inhaled nitric oxide
Secondary study objectives
Compare methods to detect change in regional lung perfusion after the delivery of inhaled nitric oxide
Other study objectives
Age
Apache II score
Arterial blood pressure, central venous pressure, pulmonary artery pressure
+22 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Electrical Impedance Tomography and Dual-Energy Computed TomographyExperimental Treatment1 Intervention
In a subset of 10 subjects (cohort 2), EIT and DECT will be performed in a row at the same type of bed and body position. In cohort 2, the measurements will be before nitric oxide (iNO) and during iNO. The OFF-ON fashion for DECT imaging is to minimize the subject's exposure to radiation and reduce the time spent in the CT room.
Group II: Electrical Impedance TomographyExperimental Treatment1 Intervention
A total of 60 subjects (cohort 1) will receive an inhaled nitric oxide (iNO) challenge (20 ppm) for 15 min. The investigators will measure ventilation and perfusion distributions using EIT before iNO ("OFF1"), after 15 min on iNO ("ON"), and after 15 min washout ("OFF2") to confirm baseline stability.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitric Oxide
2004
Completed Phase 4
~1280
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,750 Total Patients Enrolled
Maurizio Cereda, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
419 Total Patients Enrolled