An InnovaTive Approach to Ventilator-Induced Diaphragmatic Dysfunction

NCT ID: NCT02299986

Last Updated: 2015-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-06-30

Brief Summary

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'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

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Conditions

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Ventilator-induced Diaphragm Dysfunction VIDD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single arm Ultrasound measurement

Ultrasound measurement

Ultrasound measurement

Intervention Type OTHER

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

Interventions

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Ultrasound measurement

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Tom Schepens, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tom Schepens, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

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Antwerp University Hospital

Edegem, Antwerp, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 23364680 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26639081 (View on PubMed)

Other Identifiers

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B300201317057

Identifier Type: OTHER

Identifier Source: secondary_id

EC 13/12/131

Identifier Type: -

Identifier Source: org_study_id

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