An InnovaTive Approach to Ventilator-Induced Diaphragmati... | NCT02299986

Studies
An InnovaTive Approach to Ventilator-Induced Diaphragmatic Dysfunction

NCT02299986

Sponsor

University Hospital, Antwerp

Status

Completed

Last Update Posted

Jun 24, 2015Estimated

Enrollment

56Actual

Phase

Not provided

Conditions

Ventilator-induced Diaphragm Dysfunction
VIDD

Interventions

Ultrasound measurement

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
B300201317057	Other Identifier	Belgian Federal Agency for Medicines and Health products

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Nov 10, 2014

First Submission Date that Met QC Criteria

Nov 21, 2014

First Posted Date

Nov 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2015

Last Update Posted Date

Jun 24, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm Ultrasound measurement		Ultrasound measurement	Other: Ultrasound measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound measurement	Other	Thickness measurement through ultrasound. The investigators will perform daily ultrasound measurements to assess the evolution in thickness during mechanical ventilation

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Tom Schepens, MD	University Hospital, Antwerp	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Antwerp University Hospital		Edegem	Antwerp	2650	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23364680	Background	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.
26639081	Derived	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.