Diaphragmatic Function in Ventilated Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00786526
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : October 30, 2013
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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).

Condition or disease
Critically Ill

Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ventilator-Induced Diaphragmatic Dysfunction (VIDD) in Critically Ill Patients
Study Start Date : March 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Primary Outcome Measures :
  1. Respiratory function parameters [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intubated patients in intensive care unit

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00786526

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
Study Chair: Thomas SIMILOWSKI, MD, PhD Groupe Hospitalier La Pitié-Salpêtrière-Paris

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Montpellier Identifier: NCT00786526     History of Changes
Other Study ID Numbers: UF7854
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes