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Completed

NCT Number: NCT02299986

An InnovaTive Approach to Ventilator-Induced Diaphragmatic Dysfunction

'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.

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Key information

Conditions

Ventilator-induced Diaphragm Dysfunction VIDD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound measurement

Other

Thickness measurement through ultrasound. The investigators will perform daily ultrasound measurements to assess the evolution in thickness during mechanical ventilation

Primary outcomes

  1. Change in diaphragm thickness

    Time frame: Participants will be followed during their ICU stay, an expected average of 1 week

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Acronym: ITAVIDD

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2014
Registry last updated
Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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