An InnovaTive Approach to Ventilator-Induced Diaphragmatic Dysfunction

Ventilator-induced Diaphragm Dysfunction Clinical Trial

— ITAVIDD  

Official title:

An InnovaTive Approach to Ventilator-Induced Diaphragmatic Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299986
• Other study ID #: EC 13/12/131
• Secondary ID: B300201317057
• Status: Completed
• Phase: N/A
• First received: November 10, 2014
• Last updated: June 23, 2015
• Start date: April 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ventilator-induced Diaphragm Dysfunction
• VIDD

Intervention

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

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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):1455-60. doi: 10.1378/chest.11-1638. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in diaphragm thickness		Participants will be followed during their ICU stay, an expected average of 1 week	No