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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

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

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 more

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

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

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