A Biobank for Diaphragm Muscular Fiber

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.

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Key information

Conditions

Diaphragm Dysfunction Mechanical Ventilation

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

Myoblast differentiation capacity

Time frame: 24 month

Description: evaluation of ROS (reactive oxygen species) production by confocal microscopie of diaphragm fiber submitted in vitro by mechanical stress.

Secondary outcomes

Myoblast proliferation capacity

Time frame: 24 month

Description: Evaluation of diaphragm myoblast differenciation capacity in vitro under different concentration of antioxydant.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: BOTAN

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Sep 14, 2016
Registry last updated: May 14, 2025

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.

Published trials that share one or more normalized conditions with this study.

Completed