An InnovaTive Approach to Ventilator-Induced Diaphragmatic Dysfunction

NCT02299986 | Completed

• 2 other identifiers: EC 13/12/131B300201317057
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator-induced Diaphragm Dysfunction; VIDD

Outcome Measures

Primary Outcomes (1)

• Change in diaphragm thickness

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

Study Arms (1)

Single arm Ultrasound measurement

Ultrasound measurement

Other: Ultrasound measurement

Interventions

Ultrasound measurement OTHER

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

Single arm Ultrasound measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• The patient must suffer from respiratory insufficiency requiring mechanical ventilation

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (2)

• 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.

  PMID: 23364680 BACKGROUND

• 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.

  PMID: 26639081 DERIVED

Study Officials

• Tom Schepens, MD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 24, 2014
• Study Start: April 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

BE (1)