Clinical trial NCT02299986: An InnovaTive Approach to Ventilator-Induced Diaphragmatic Dysfunction
Official title: An InnovaTive Approach to Ventilator-Induced Diaphragmatic Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator-induced Diaphragm Dysfunction
VIDD
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that are admitted in ICU and who require mechanical ventilation will be screened for inclusion, and participants will be enrolled after informed consent. The study population will be a mixed medical/surgical cohort, selected with non-probability sampling because of the different eligibility criteria.

Brief summary: 'Ventilator-Induced Diaphragmatic Dysfunction (VIDD) was originally described by Vassilakopoulos and Petrof in 1998, where it is used to cover the effects of mechanical ventilation and respiratory muscle unloading on the diaphragm. A recent article by Grosu and colleagues has demonstrated that the thickness of the diaphragm decreases with about 6% a day in a small cohort of mechanically ventilated patients. This is a longitudinal, single-centre, observational cohort study to examine the long-term effects of invasive mechanical ventilation on the diaphragm, and to study the risk factors associated with VIDD.


Eligibility criteria: Inclusion Criteria:

* The patient must suffer from respiratory insufficiency requiring mechanical ventilation

Exclusion Criteria:

* The patient has been hospitalized and mechanically ventilated (invasive or non- invasive) in the period up to 1 year before start of the study.
* The patient is known or suspected to have an anatomical malformation of the diaphragm.
* The patient suffers from a disease that may impair diaphragmatic function:

  * Central neural disease at the level of the brain (Multiple sclerosis, stroke, Arnold-Chiari malformation) and spinal cord (quadriplegia, amyotrophic lateral sclerosis, poliomyelitis, spinal muscular atrophy, syringomyelia).
  * Neural disease of the phrenic nerve (Guillain-Barré syndrome, tumor compression, neuralgic neuropathy, chronic inflammatory demyelinating polyneuropathy, Charcot-Marie-Tooth disease).
  * Disorders of the neuromuscular junction (Myasthenia gravis, Lambert- Eaton syndrome, botulism, organophosphate poisoning).
  * Muscular diseases (muscular dystrophies, myositis (infectious, inflammatory, metabolic).
* The patient is known or suspected to have a psychiatric illness inhibiting his/her cooperation with the study protocol or possibly obscuring the obtained results.
* The patient has been mechanically ventilated for over 24 hours before the first ultrasonographic measurement can be performed.

Primary outcomes:
measure: Change in diaphragm thickness
timeFrame: Participants will be followed during their ICU stay, an expected average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Tom Schepens, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grosu HB, Lee YI, Lee J, Eden E, Eikermann M, Rose KM. Diaphragm muscle thinning in patients who are mechanically ventilated. Chest. 2012 Dec;142(6):1455-1460. doi: 10.1378/chest.11-1638.
citation: Schepens T, Verbrugghe W, Dams K, Corthouts B, Parizel PM, Jorens PG. The course of diaphragm atrophy in ventilated patients assessed with ultrasound: a longitudinal cohort study. Crit Care. 2015 Dec 7;19:422. doi: 10.1186/s13054-015-1141-0.