NCT05801224 Vascular ARDS Recruitment After Inhaled Nitric Oxide
| NCT ID | NCT05801224 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-07-10 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2026-07-10 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Prone position has been used for several years in the care of ARDS patients and has been demonstrated to improve survival in more severe patients. It is not known how iNO and prone positioning interact in determining the distribution of pulmonary perfusion and whether their combine use can benefit ARDS patients. 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 and to prone positioning 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 can measure the lung regional perfusion responses to prone position, applied alone and in combination with iNO. 3. If EIT is comparable to dual-energy computed tomography (DECT), the gold-standard method, in the detection of changes in regional lung perfusion due to iNO. 4. If EIT can be an imaging marker to identify ARDS severity Participants will be divided into three cohorts: 1. Sub-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) in the supine position 2. Sub-Cohort 2 (N=10): Participants will be asked to be monitored by EIT before and during the administration of iNO (20 ppm) for 15 minutes (OFF-ON) in both the supine and in the prone position. The same subjects will be monitored also with DECT in the supine position and then after 30 minutes in the prone position (without NO administration). 3. Sub-Cohort 3 (N=10): In this subset of Sub-Cohort 1, subjects will be asked to be monitored also with DECT (in addition to EIT) in the supine body position before iNO and after 15 minutes while receiving iNO.
Eligibility Criteria
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.
Contact & Investigator
Maurizio Cereda, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05801224 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05801224 currently recruiting?
Yes, NCT05801224 is actively recruiting participants. Contact the research team at mcereda@mgh.harvard.edu for enrollment information.
Where is the NCT05801224 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05801224 clinical trial?
NCT05801224 is sponsored by Massachusetts General Hospital. The principal investigator is Maurizio Cereda, MD at Massachusetts General Hospital. The trial plans to enroll 70 participants.