Combining inhaled nitric oxide and prone positioning for ARDS treatment

A Pilot Study of the Effect of the Combination of Inhaled Nitric Oxide and Prone Position Under EIT Monitoring on Efficacy in Patients with ARDS

This study tests if using inhaled nitric oxide along with lying patients on their stomachs can help improve breathing for people with severe lung problems who are on ventilators.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Northern Jiangsu People's Hospital (other)
• Locations: 1 site (Yangzhou, Jiangsu)
• Trial ID: NCT06741137 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the effects of using inhaled nitric oxide in combination with prone positioning on patients suffering from moderate to severe Acute Respiratory Distress Syndrome (ARDS) who are on mechanical ventilation. The approach aims to enhance oxygenation and improve overall respiratory function by utilizing both interventions simultaneously. The study will monitor the efficacy of this combination therapy through electrical impedance tomography (EIT) to assess lung function and ventilation distribution. The goal is to determine if this combined method can lead to better clinical outcomes for ARDS patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-80 with moderate to severe ARDS who are currently on mechanical ventilation.

Not a fit: Patients with severe asthma, COPD exacerbations, or other conditions that complicate prone positioning or hemodynamic stability may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve oxygenation and recovery rates in patients with ARDS.

How similar studies have performed: While the combination of inhaled nitric oxide and prone positioning is a novel approach, similar studies have shown promising results with individual therapies in ARDS management.

Eligibility criteria

Inclusion Criteria:

1. Age 18-80 years;
2. Patients with moderate to severe ARDS on mechanical ventilation

Exclusion Criteria:

1. Patients with severe asthma or acute exacerbation of chronic obstructive pulmonary disease (COPD), lung tumors, post-lung resection, and post-lung transplantation.
2. Patients with hemodynamic instability requiring vasopressor support: dopamine or dobutamine \>15 µg/kg/min, norepinephrine \>0.3 µg/kg/min.
3. Cardiogenic pulmonary edema.
4. Patients with severe facial deformities, facial trauma, or severe thoracoabdominal trauma that precludes prone positioning ventilation.
5. Mid to late pregnancy.
6. Patients with a history of malignancy or other irreversible diseases/conditions, including those in the terminal stage.
7. Patients expected to be discharged soon or requiring invasive mechanical ventilation for less than 24 hours.
8. Patients currently participating in other studies.

Where this trial is running

Yangzhou, Jiangsu

• Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Chuanqing Zhang Study Director

Conditions: ARDS