Diaphragmatic Function in Ventilated Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT00786526
First received: November 5, 2008
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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).


Condition
Critically Ill

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ventilator-Induced Diaphragmatic Dysfunction (VIDD) in Critically Ill Patients

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Respiratory function parameters [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: March 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Intubated patients in intensive care unit

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786526

Locations
France
Department of Anesthesia and Critical Care (DAR B)
Saint-Eloi University Hospital of Montpellier, Montpellier, France, 34295
Service de Pneumologie et Réanimation
Groupe Hospitalier La Pitié-Salpêtrière-Paris, Paris, France, 75013
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Study Chair: Thomas SIMILOWSKI, MD, PhD Groupe Hospitalier La Pitié-Salpêtrière-Paris
  More Information

No publications provided by University Hospital, Montpellier

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT00786526     History of Changes
Other Study ID Numbers: UF7854
Study First Received: November 5, 2008
Last Updated: October 29, 2013
Health Authority: France: Direction Générale de la Santé

Keywords provided by University Hospital, Montpellier:
Mechanical ventilation
Ventilator induced diaphragmatic dysfunction
Weaning
Neuromuscular diseases- Respiratory function tests
Intubated patients in intensive care unit

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014