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

Investigating the Impact of Combined Inhaled Nitric Oxide and Prone Positioning on the Efficacy in ARDS Patients

Study Overview

• Status: Recruiting
• Conditions: ARDS
• Intervention / Treatment: Procedure: inhaled nitric oxide combined with prone position ventilation

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chuanqing Zhang Study Director; Phone Number: 1504572590; Email: 1504572590@qq.com

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 211400
      • Recruiting
      • Northern Jiangsu People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: inhaled nitric oxide combined with prone position ventilation	Procedure: inhaled nitric oxide combined with prone position ventilation; inhaled nitric oxide combined with prone position ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intratidal gas distribution	12 hours

Collaborators and Investigators

• Sponsor: Northern Jiangsu People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Antioxidants; Protective Agents; Respiratory System Agents; Free Radical Scavengers; Anti-Asthmatic Agents; Bronchodilator Agents; Vasodilator Agents; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Nitric Oxide
• Other Study ID Numbers: 2024ky074

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No