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

NCT06741137 | Recruiting

• 1 other identifier: 2024ky074
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ARDS

Outcome Measures

Primary Outcomes (1)

• Intratidal gas distribution

  12 hours

Study Arms (1)

inhaled nitric oxide combined with prone position ventilation

EXPERIMENTAL

Procedure: inhaled nitric oxide combined with prone position ventilation

Interventions

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years;
• Patients with moderate to severe ARDS on mechanical ventilation

You may not qualify if:

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

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 211400, China

RECRUITING

Central Study Contacts

Chuanqing Zhang Study Director

CONTACT

1504572590; 1504572590@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 18, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 10, 2025

Record last verified: 2024-10

Locations

CN (1)