A Biobank for Diaphragm Muscular Fiber

Completed

• Conditions: Mechanical Ventilation; Diaphragm Dysfunction

• Registration Number: NCT02900300
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-14
• Study Start: 2022-02-18
• Primary Completion: 2024-05-23
• Study Completion: 2024-05-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myoblast differentiation capacity	24 month	Description: evaluation of ROS (reactive oxygen species) production by confocal microscopie of diaphragm fiber submitted in vitro by mechanical stress.

Secondary Outcome Measures

Name	Time	Method
Myoblast proliferation capacity	24 month	Description: Evaluation of diaphragm myoblast differenciation capacity in vitro under different concentration of antioxydant.

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Montpellier, France