A Biobank for Diaphragm Muscular Fiber (BOTAN)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation; Diaphragm Dysfunction

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Stefan MATECKI, MD, PhD; Phone Number: 33 467335908; Email: stephan.matecki@umontpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • University Hospital
    • Contact: stephan MATECKI, MD, PhD; Email: stephan.matecki@umontpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient undergoing a surgery for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Estimated): February 18, 2025
• Study Completion (Estimated): February 18, 2025

Study Registration Dates

• First Submitted: August 26, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimated): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RECHMPL15_0389

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED