Mechanism of Nitric Oxide on Ventilator-induced Diaphragm Dysfunction with Extracorporeal Membrane Lung Assistance
NCT ID: NCT06660784
Last Updated: 2024-10-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Total Enrollment
80 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-01-16
Study Completion Date
2025-12-30
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Tracheal Intubation
Extracorporeal Membrane Oxygenation
Nitric Oxide
Ventilator-induced Diaphragmatic Dysfunction
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Interventions
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Nitric Oxide
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.
Intervention Type
DRUG
Eligibility Criteria
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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.
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.
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Zhongnan Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Site Status
Countries
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China
References
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Other Identifiers
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PTXM2024028
Identifier Type: -
Identifier Source: org_study_id
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