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

NCT06660784 | Active Not Recruiting

• 1 other identifier: PTXM2024028
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

ventilator-induced diaphragm dysfunction; nitric oxide; extracorporeal membrane oxygenation; oxidative stress; endoplasmic reticulum stress

Outcome Measures

Primary Outcomes (1)

• Diaphragm function

  Continuous POCUS monitoring of diaphragm function during mechanical ventilation, including diaphragm thickness, diaphragm thickening fraction, diaphragm excursion, etc

  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.

Secondary Outcomes (2)

• Inflammatory cytokines

  The fixed time point on the 1st, 2nd, 3rd, 4th, 5th, 6th and 7th day.

• Oxidative stress markers

  The fixed time point on the 1st, 2nd, 3rd, 4th, 5th, 6th and 7th day.

Interventions

Nitric Oxide DRUG

Depending on the indication, the subjects 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of mechanical ventilation with or without ECMO assistance in emergency ward

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

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Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Interventions

Nitric Oxide

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: January 16, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)