Grip Test in Ventilated ICU Patients | NCT01305421

Studies
Grip Test in Ventilated ICU Patients

NCT01305421

Sponsor

Centre Hospitalier Universitaire Brugmann

Status

Unknown status

Last Update Posted

Feb 28, 2011Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Mechanically Ventilated ICU Patients

Interventions

grip test

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

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Mar 2011Estimated

Completion Date

Apr 2011Estimated

First Submitted Date

Feb 25, 2011

First Submission Date that Met QC Criteria

Feb 25, 2011

First Posted Date

Feb 28, 2011Estimated

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

Feb 25, 2011

Last Update Posted Date

Feb 28, 2011Estimated

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

ICU patients do experience extubation failure. Guidelines rarely include muscle strength criteria. Prior work indicates that grip strength is a reliable surrogate for muscle strength. The purpose of the study is to assess the success rate of mechanical ventilation weaning based on the grip test.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
grip test	Procedure	Muscle strength measurement by hand-held dynamometer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Extubation success		48 hours without reintubation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

mechanically ventilated ICU patients

Exclusion Criteria:

tracheotomy

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Brugmann	Recruiting	Brussels		1020	Belgium