Diaphragmatic Function in Ventilated Patients

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

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).

Study Overview

• Status: Completed
• Conditions: Critically Ill

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• France
  • Montpellier
    • Saint-Eloi University Hospital of Montpellier, Montpellier, France, 34295
      • Department of Anesthesia and Critical Care (DAR B)
  • Paris
    • Groupe Hospitalier La Pitié-Salpêtrière-Paris, Paris, France, 75013
      • Service de Pneumologie et Réanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Intubated patients in intensive care unit

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Respiratory function parameters	6 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Chair: Thomas SIMILOWSKI, MD, PhD, Groupe Hospitalier La Pitié-Salpêtrière-Paris

Publications and helpful links

General Publications

• Demoule A, Molinari N, Jung B, Prodanovic H, Chanques G, Matecki S, Mayaux J, Similowski T, Jaber S. Patterns of diaphragm function in critically ill patients receiving prolonged mechanical ventilation: a prospective longitudinal study. Ann Intensive Care. 2016 Dec;6(1):75. doi: 10.1186/s13613-016-0179-8. Epub 2016 Aug 5.
• Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: November 5, 2008
• First Submitted That Met QC Criteria: November 5, 2008
• First Posted (Estimate): November 6, 2008

Study Record Updates

• Last Update Posted (Estimate): October 30, 2013
• Last Update Submitted That Met QC Criteria: October 29, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Weaning; Mechanical ventilation; Ventilator induced diaphragmatic dysfunction; Neuromuscular diseases- Respiratory function tests; Intubated patients in intensive care unit
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: UF7854