NCT05801224

Vascular ARDS Recruitment After Inhaled Nitric Oxide

Suspended NA Last updated 8 May 2025

What this trial tests

NA trial testing Nitric Oxide in Acute Respiratory Distress Syndrome in 70 participants. Suspended.

Timeline

1 July 2026

Primary endpoint
31 December 2028

31 December 2028

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Suspended
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	70
Start date	1 July 2026
Primary completion	31 December 2028
Estimated completion	31 December 2028
Sites	1 location across United States

Drugs / interventions tested

• Nitric Oxide (NITRIC OXIDE) — full drug profile →

Conditions studied

• Acute Respiratory Distress Syndrome — all drugs for Acute Respiratory Distress Syndrome →
• Ventilation Perfusion Mismatch — all drugs for Ventilation Perfusion Mismatch →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 80, any sex, with Acute Respiratory Distress Syndrome or Ventilation Perfusion Mismatch. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute respiratory distress syndrome (ARDS) is when a person's lungs become inflamed, which can be caused by infection, trauma, surgery, blood transfusion, or burn. ARDS often leads to a situation where the person cannot breathe independently and needs machines' help. Once the lungs are inflamed, the small air sacs responsible for exchanging gases (i.e., ventilation) and the blood flow in the lungs (i.e., perfusion) can be affected. In the past, most research focused on studying ventilation physiology and how to help people breathe with machines. Less was done on perfusion because it requires imaging techniques such as computed tomography with intravenous contrast and radiation. One treatment option for low oxygen levels is inhaled nitric oxide (iNO), a gas that can dilate the lung blood vessels and improve oxygenation; however, it is not always clear whether this treatment will work. Electrical Impedance Tomography (EIT) is a bedside and accessible imaging technique that is radiation-free and non-invasive and can potentially detect changes in lung perfusion. EIT can perform multiple measurements; it is portable and accessible. This prospective interventional study aims to assess changes in regional blood perfusion in the lungs of patients with ARDS in response to iNO utilizing EIT. The main questions it aims to answer are:

1. If EIT can measure lung regional perfusion response to an iNO challenge of 20ppm for 15 minutes.
2. If EIT is comparable to dual-energy computed tomography (DECT), the gold-standard method to detect changes in regional lung perfusion.
3. If EIT can be an imaging marker to identify ARDS severity

Participants will be divided into two cohorts:

1. Cohort 1 (n=60): Participants will be asked to be monitored by EIT before, during, and after the administration of iNO (20 ppm) for 15 minutes (OFF-ON-OFF)
2. Cohort 2 (N=10): Participants will be asked to be monitored by EIT and DECT before and during the administration of iNO (20 ppm) for 15 minutes (OFF-ON).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.