An InnovaTive Approach to Ventilator-Induced Diaphragmatic Dysfunction

Completed

• Conditions: VIDD; Ventilator-induced Diaphragm Dysfunction
• Interventions: Other: Ultrasound measurement

• Registration Number: NCT02299986
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-11-21
• Study First Posted: 2014-11-24
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-23
• Last Update Posted: 2015-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single arm Ultrasound measurement	Ultrasound measurement	Ultrasound measurement

Primary Outcome Measures

Name	Time	Method
Change in diaphragm thickness	Participants will be followed during their ICU stay, an expected average of 1 week

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium