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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
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, see Learn About Clinical Studies.

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 November 19, 2014