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

October 25, 2024 updated by: Zhongnan Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Zhongnan Hospital of Wuhan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongnan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTXM2024028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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