Vascular ARDS Recruitment After Inhaled Nitric Oxide

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In adults with ARDS, the lungs’ air sacs and blood flow can be mismatched, contributing to low oxygen. The study uses electrical impedance tomography (EIT) and dual-energy CT to monitor how inhaled nitric oxide affects ventilation and perfusion while patients are in supine and prone positions. Participants are divided into three sub-cohorts to compare questions about how iNO changes lung blood flow and oxygenation, including before, during, and after administration. The trial is conducted at Massachusetts General Hospital with a plan to enroll up to 70 intubated ICU patients who meet Berlin criteria for mild to moderate ARDS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult intubated and mechanically ventilated patients (≥ 18 years old) admitted to the intensive care unit (ICU)
* ARDS diagnosis with mild to moderate severity by Berlin criteria1 (100 mmHg \< PaO2/FiO2 \<= 300 mmHg)
* Presence of an arterial line for blood gas measurement and blood pressure monitoring and of a central line for hypertonic saline injection

Exclusion criteria

* Suspected pregnancy, pregnancy or less than six weeks postpartum
* Younger than 18 years or older than 80 years
* Patients with thorax perimeter not within the range of 37.5 - 134cm
* Baseline methemoglobin ≥ 5%
* Hemoglobin level less than 7 g/dl
* Subjects enrolled in another interventional research study
* Presence of pneumothorax
* Usage of any devices with the electric current generation, such as a pacemaker or internal cardiac defibrillator
* Past medical history of severe lung disease
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Cytochrome b5 reductase deficiency
* Sickle cell disease
* Patients that are receiving inhaled pulmonary vasodilators at the time of the enrollment
* Hemodynamic instability is defined as:

  * Persistent systolic blood pressure \<90 mmHg and/or \>180 mmHg despite the use of vasopressor or vasodilators, or
  * Requiring an increment in inotropic vasopressors over the past two hours just before enrollment: more than 15 mcg/min for norepinephrine and dopamine, more than 10 mcg/min in epinephrine, and more than 50 mcg/ min for phenylephrine.
* Increase in FiO2 \> 20%, increase in PEEP \> 5cmH2O over the past two hours just before enrollment
* Hypernatremia (serum sodium \> 150 mEq/L)
* Patients cannot be enrolled for DECT if they have:

  * History of allergic reaction to intravenous contrast
  * Renal dysfunction on the day of the study (serum creatinine \> 1.5 mg/dL)
* Limited to sub-cohort 2: contraindications to prone positioning.

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Maurizio Cereda, MD — Massachusetts General Hospital
• Study coordinator: Maurizio F Cereda, MD
• Email: mcereda@mgh.harvard.edu
• Phone: 6177263030

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Right‑heart function and heart–lung interaction during ARDS with mechanical ventilation

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• Umbilical‑cord mesenchymal stem cell and secretome therapy for severe ARDS

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• Human umbilical cord mesenchymal stem cell injection for moderate to severe ARDS

  This will test whether a single injection of human umbilical cord mesenchymal stem cells can help adults with moderate to severe ARDS that hasn't improved after standard treatment.

  Recruiting Phase 1/2 Changchun Tuohua Pharmaceutical Co., Ltd. · Wuhan, Hubei · NCT07413978

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.