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NCT Number: NCT06660784

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

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.

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Key information

Conditions

Tracheal Intubation Extracorporeal Membrane Oxygenation Nitric Oxide Ventilator-Induced Diaphragmatic Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Diaphragm function

    Time frame: 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 outcomes

  1. Inflammatory cytokines

    Time frame: 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.

  2. Oxidative stress markers

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

    ROS, SOD, MDA, GSH, etc.

Sponsors and collaborators

Lead sponsor

Zhongnan Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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