Clinical trial NCT00786526: Diaphragmatic Function in Ventilated Patients
Official title: Ventilator-Induced Diaphragmatic Dysfunction (VIDD) in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill
Keywords: Mechanical ventilation
Ventilator induced diaphragmatic dysfunction
Weaning
Neuromuscular diseases- Respiratory function tests
Intubated patients in intensive care unit
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2008-11-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intubated patients in intensive care unit

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).


Eligibility 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

Primary outcomes:
measure: Respiratory function parameters
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Eloi University Hospital of Montpellier
country: France
facility: Department of Anesthesia and Critical Care (DAR B)
state: Montpellier
city: Groupe Hospitalier La Pitié-Salpêtrière-Paris
country: France
facility: Service de Pneumologie et Réanimation
state: Paris
Study officials:
affiliation: Groupe Hospitalier La Pitié-Salpêtrière-Paris
name: Thomas SIMILOWSKI, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.