Mechanism of Nitric Oxide on Ventilator-induced Diaphragm Dysfunction with Extracorporeal Membrane Lung Assistance

Active, not recruiting

• Conditions: Tracheal Intubation; Extracorporeal Membrane Oxygenation; Nitric Oxide; Ventilator-induced Diaphragmatic Dysfunction

• Registration Number: NCT06660784
• Lead Sponsor: Zhongnan Hospital

Brief Summary

The goal of this clinical trial is to explore the effect of NO treatment on diaphragm function after mechanical ventilation with ECMO assistance. We expect to enroll a total of 80 patients who will receive mechanical ventilation and mechanical ventilation combined with ECMO treatment. Depending on the indication, they will be given NO treatment or not. In ECMO assisted mechanical ventilation + NO treatment group, the subjects will be randomly assigned to NO treatment via ventilator or membrane oxygenator. The main questions it aims to answer are:

1. Observing the influences and potential therapeutic effects of different NO insertion methods through ventilator or membrane oxygenator on the occurrence and development of ventilator-induced diaphragm (VIDD) dysfunction during ECMO assisted mechanical ventilation.

2. Exploring the potential key molecular mechanisms of NO treatment on the occurrence and development of VIDD after ECMO assisted mechanical ventilation.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-16
• Status Verified: 2024-09
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Age ≥ 18 years;
2. Tracheal intubation in our emergency department;
3. Expected survival time ≥ 72 hours;
4. Family members agree to participate and sign the informed consent form.

Exclusion Criteria

1. Pregnant women;
2. Patients with diaphragmatic hernia or other known diaphragmatic diseases and injuries;
3. Patients with mechanical ventilation treatment within 3 months;
4. Thoracic or abdominal tumor invading the diaphragm;
5. A large amount of ascites raises the diaphragm position;
6. Upper respiratory tract malformation;
7. Trauma leading to chest collapse, etc.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diaphragm function	We starts POCUS within 1 hour (1h) after mechanical ventilation, and continuously monitoring the diaphragm function at 6h, 12h, 24h, 48h, 72h, 96h, 120h, 144h and 168h respectively. POCUS will be terminated if the patient dies.	Continuous POCUS monitoring of diaphragm function during mechanical ventilation, including diaphragm thickness, diaphragm thickening fraction, diaphragm excursion, etc

Secondary Outcome Measures

Name	Time	Method
Inflammatory cytokines	The fixed time point on the 1st, 2nd, 3rd, 4th, 5th, 6th and 7th day.	TNF - α, IL-1β , IL-6, IL-8, IL-10, etc.
Oxidative stress markers	The fixed time point on the 1st, 2nd, 3rd, 4th, 5th, 6th and 7th day.	ROS, SOD, MDA, GSH, etc.

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China