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A Biobank for Diaphragm Muscular Fiber (BOTAN)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Mechanical Ventilation
Diaphragm Dysfunction

Study type

Observational

Funder types

Other

Identifiers

NCT02900300
RECHMPL15_0389

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Stefan MATECKI, MD, PhD

Data sourced from clinicaltrials.gov

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