Diaphragmatic Function in Ventilated Patients

NCT00786526 | Completed

• 1 other identifier: UF7854
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 2

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).

Conditions

Critically Ill

Keywords

Mechanical ventilation; Ventilator induced diaphragmatic dysfunction; Weaning; Neuromuscular diseases- Respiratory function tests; Intubated patients in intensive care unit

Outcome Measures

Primary Outcomes (1)

• Respiratory function parameters

  6 weeks

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intubated patients in intensive care unit

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

Department of Anesthesia and Critical Care (DAR B)

Saint-Eloi University Hospital of Montpellier, Montpellier, 34295, France

Location

Service de Pneumologie et Réanimation

Groupe Hospitalier La Pitié-Salpêtrière-Paris, Paris, 75013, France

Location

Related Publications (2)

• 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.

  PMID: 27492005 DERIVED

• 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.

  PMID: 23641946 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas SIMILOWSKI, MD, PhD

  Groupe Hospitalier La Pitié-Salpêtrière-Paris

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 6, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 30, 2013

Record last verified: 2013-10

Locations

FR (2)