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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00786526
Other study ID # UF7854
Secondary ID
Status Completed
Phase N/A
First received November 5, 2008
Last updated October 29, 2013
Start date March 2008
Est. completion date July 2010

Study information

Verified date October 2013
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority France: Direction Générale de la Santé
Study type Observational

Clinical Trial Summary

Animal studies showed that controlled mechanical ventilation (CMV) can induce dysfunction of the diaphragm, resulting in an early-onset and progressive decrease in diaphragmatic force-generating capacity, called ventilator-induced diaphragmatic dysfunction (VIDD).


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Invasive mechanical ventilation (tracheally intubated or tracheotomized) less than 48h.·

- Duration of mechanical ventilation for at least 72h.·

- Subject itself or its next of kin has given written informed consent

Exclusion Criteria:

- Patient is less than 18 years or more than 85 years of age·

- The attending physician refuses to allow enrollment·

- The patient refuses informed consent

- Next of kin is unavailable or refuses informed consent·

- Pregnant or breast-feeding female.

- A pregnancy test will be performed in all female patients less than 60 years of age.·

- Any contraindication to use cervical magnetic stimulation (mechanical cardiac assist device …).·

- Presence or suspicion of prior diaphragm injury or chronic disease·

- Presence or suspicion of a central nervous system (CNS) disorder, including (but not limited to): CNS infarction, bleeding, tumor, or infection

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Service de Pneumologie et Réanimation Groupe Hospitalier La Pitié-Salpêtrière-Paris Paris
France Department of Anesthesia and Critical Care (DAR B) Saint-Eloi University Hospital of Montpellier 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 Respiratory function parameters 6 weeks No
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