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

NCT ID: NCT06741137

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-12-31

Brief Summary

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

Conditions

ARDS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

inhaled nitric oxide combined with prone position ventilation

Group Type: EXPERIMENTAL

inhaled nitric oxide combined with prone position ventilation

Intervention Type: PROCEDURE

inhaled nitric oxide combined with prone position ventilation

Interventions

inhaled nitric oxide combined with prone position ventilation

inhaled nitric oxide combined with prone position ventilation

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern Jiangsu People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chuanqing Zhang Study Director

Role: CONTACT

1504572590@qq.com

1504572590

Other Identifiers

2024ky074

Identifier Type: -

Identifier Source: org_study_id