Inhaled Nitric Oxide in Severe Obesity

Conditions

• Hypoxemic Respiratory Failure
• Nitric Oxide
• Obesity
• Respiratory Insufficiency

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nitric oxide — DEVICE
  20ppm for 15 minutes delivered by INO max(Nitric Oxide) Company : INO therapeutics, Inc.

Study Details

The goal of this clinical trial is to learn about the effects of inhaled nitric oxide on oxygenation and lung perfusion in participants with severe obesity who have acute hypoxemic respiratory failure and are on mechanical ventilation The main questions it aims to answer are: 1. In acute hypoxemic respiratory failure, what are the effects of inhaled nitric oxide on oxygenation in participants with severe obesity compared to participants with normal body weight. 2. In acute hypoxemic respiratory failure, what are the effects of inhaled nitric oxide on lung perfusion and heart function in participants with severe obesity compared to participants with normal body weight. 3. In acute hypoxemic respiratory failure, does severe obesity impact nitric oxide signaling pathways? Participants with acute hypoxemic respiratory failure will be exposed to inhaled nitric oxide (20 ppm) while being clinically monitored.

Key Dates

Start date

Oct 31, 2026

Status verified

May 2026

Primary completion

Oct 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

60 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Acute hypoxemic respiratory failure
  Participants (n = 40) with acute hypoxemic respiratory failure will receive inhaled nitric oxide (20 ppm) for 15 min.
• No Intervention: Participants without acute hypoxemic respiratory failure
  Participants (n = 20) without acute hypoxemic respiratory failure will not receive inhaled nitric oxide

Primary Outcome Measure

Intrapulmonary shunt [ Time Frame: 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. ]

Central Contacts

• Timothy Gaulton, MD, MSc
  6177263030
  [email protected]
• Maurizio Cereda, MD
  6177263030
  [email protected]

Locations (1)

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