Inhaled Nitric Oxide in Severe Obesity

ConditionsObesity Respiratory Insufficiency Hypoxemic Respiratory Failure Nitric Oxide

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Acute hypoxemic respiratory failure, defined as persistent hypoxemia (PaO2/FiO2 ≤ 300 mmHg or SpO2/FiO2 ≤ 315) and on invasive mechanical ventilation for < 72 hours

Presence of an arterial and central venous catheter (for blood gas measurement)

Admitted to a participating MGH ICU

Disqualifiers

Age < 18 years

Pregnancy or known active breastfeeding

Prisoner or Incarceration

Inability or unwillingness of subject or legal surrogate/representative to give written informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Acute hypoxemic respiratory failureExperimental treatment 1 intervention

Group B: Participants without acute hypoxemic respiratory failureNo intervention 0 interventions

Trial outcomes

Primary outcomes

Intrapulmonary shunt

Intrapulmonary shunt will be defined as the difference in intrapulmonary shunt (%) to inhaled nitric oxide. Intrapulmonary shunt will be defined using the modified Berggren equation based on central venous and arterial oxygen concentrations from a central venous and peripheral arterial catheter.

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.

Secondary outcomes

Regional pulmonary perfusion

In participants who are already receiving neuromuscular blocking agents, regional pulmonary perfusion will be measured and defined as the % change to inhaled nitric oxide in 4 lung regions of interest (right upper, right lower, left upper, left lower)

Time frame

Regional pulmonary perfusion will be assessed before inhaled nitric oxide, at 15 minutes after inhaled nitric oxide, and at 15 minutes after inhaled nitric oxide discontinuation.

Gas exchange

Measures of gas exchange be defined by Pa02/Fi02 and dead space fraction in response to inhaled nitric oxide

Time frame

Gas exchange will be assessed before inhaled nitric oxide, at 15 minutes after inhaled nitric oxide, and at 15 minutes after inhaled nitric oxide discontinuation.

Right ventricular systolic pressure

The investigators will measure right ventricular systolic pressure, an ultrasound surrogate of pulmonary arterial pressure, in response to inhaled nitric oxide

Time frame

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.

Other outcomes

Nitric oxide activity

Nitric oxide activity will be measured by nitrate, nitrite, nitrosyl-hemoglobin using chemiluminescence in response to inhaled nitric oxide

Time frame

Nitric oxide activity will be assessed before inhaled nitric oxide, at 15 minutes after inhaled nitric oxide, and at 15 minutes after inhaled nitric oxide discontinuation. Nitric oxide activity will be measured in control participants (single timepoint).

Nitric oxide signaling pathways

The investigators will measure pro-inflammatory cytokines (INF-α, IL-6, IL-8, IL-10, IL-1β, TNF-α, MCP-1) using multiplex enzyme-linked immunosorbent assays and endothelial glycocalyx fragments (heparan sulfate, chondroitin sulfate, hyaluronic acid) using Liquid Chromatography (UPLC)-tandem mass spectrometry.

Time frame

Biomarkers will be measured after enrollment in participants with and without acute hypoxemic respiratory failure (single time point)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: