Clinical trial NCT06660784: Mechanism of Nitric Oxide on Ventilator-induced Diaphragm Dysfunction with Extracorporeal Membrane Lung Assistance
Official title: Mechanism of Nitric Oxide on Ventilator-induced Diaphragm Dysfunction with Extracorporeal Membrane Lung Assistance
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of mechanical ventilation with or without ECMO assistance in emergency ward

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diaphragm function
timeFrame: 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:
measure: Inflammatory cytokines
timeFrame: The fixed time point on the 1st, 2nd, 3rd, 4th, 5th, 6th and 7th day.
measure: Oxidative stress markers
timeFrame: The fixed time point on the 1st, 2nd, 3rd, 4th, 5th, 6th and 7th day.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
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