Diaphragmatic Function in Ventilated Patients

Critically Ill Clinical Trial

Official title:

Ventilator-Induced Diaphragmatic Dysfunction (VIDD) in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786526
• Other study ID #: UF7854
• 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

• Critical Illness
• Critically Ill

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