A Biobank for Diaphragm Muscular Fiber

Mechanical Ventilation Clinical Trial

— BOTAN  

Official title:

Constitution of a Biobank to Optimize in Vitro an Antioxydant Treatment for Diaphragm Dysfunction Induced by Mechanical Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02900300
• Other study ID #: RECHMPL15_0389
• Status: Recruiting
• Start date: February 18, 2022
• Est. completion date: February 18, 2025

Study information

• Verified date: August 2023
• Source: University Hospital, Montpellier
• Contact: Stefan MATECKI, MD, PhD
• Phone: 467335908
• Email: stephan.matecki[@]umontpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This non-interventional study focuses on mechanical ventilation used in intensive care unit to supplement ventilatory function in patients. Mechanical ventilation can "paradoxically" be at the origin of complications that can be life-threatening in patients. This muscular pathology is called ventilation-induced diaphragmatic dysfunction (DDIV).

Diaphragmatic muscle collected during a digestive surgery for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm from the care will be conserved. The diaphragm biopsy from the care will be retained for biobanking to obtain myoblast in culture which will differentiate in Diaphragm fiber. Then these fibers will be submitted under mechanical stress condition similar to those imposed in vivo by mechanical ventilation to validate in human a model in vitro of diaphragm dysfunction induced by mechanical ventilation. Then the second part of the study will be to evaluate with this model, the efficiency of an antioxidant therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 18, 2025
• Est. primary completion date: February 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• age between 30 and 65 years old

• patient treated by the digestive surgery department of Montpellier University Hospital for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm

• Non-smoker patient for more than 6 months

• patient clinically stable at the time of the study, ie not requiring any treatment

Exclusion Criteria:

• Patients undergoing treatment with antibiotics or corticosteroids, or recently within the last 4 months

• Patients with a body mass index > 30

• Patients with any criteria that may in themselves impair respiratory muscle function such as chronic obstructive pulmonary disease, heart failure, systemic infection, neuromuscular pathology, psychiatric pathology or metabolic disorder.

Patients with coagulopathy or thrombocytopenia.

Related Conditions & MeSH terms

• Diaphragm Dysfunction
• Mechanical Ventilation

Locations

Country	Name	City	State
France	University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myoblast differentiation capacity	Description: evaluation of ROS (reactive oxygen species) production by confocal microscopie of diaphragm fiber submitted in vitro by mechanical stress.	24 month
Secondary	Myoblast proliferation capacity	Description: Evaluation of diaphragm myoblast differenciation capacity in vitro under different concentration of antioxydant.	24 month