NCT02946502

Brief Summary

The purpose of this study is to test the association between ICU acquired weakness as evaluated by dominant handheld dynamometry (handgrip) and the mechanical ventilation weaning outcome

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 17, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 2, 2020

Status Verified

July 1, 2020

Enrollment Period

2.8 years

First QC Date

October 18, 2016

Last Update Submit

July 1, 2020

Conditions

Ventilator WeaningHand StrengthRespiration

Outcome Measures

Primary Outcomes (1)

  • extubation outcome according to handgrip strength value

    Each mechanical ventilation weaning trial

    7 days

Secondary Outcomes (7)

  • Association between handgrip strength and difficulty of weaning according to guidelines

    7 days

  • Association between handgrip strength and cough strength as assessed through peak expiratory flow evaluated with a portable spirometer

    7 days

  • Association between handgrip strength and maximal inspiratory strength during a brief inspiratory valve occlusion on the ventilator

    7 days

  • Association between handgrip strength and peripheral muscular strength evaluated by the Medical Research Council score

    7 days

  • Association between handgrip strength and the peripheral muscular strength evaluated by the Medical Research Council score. (Global score and its components)

    7 days

  • +2 more secondary outcomes

Study Arms (1)

Handheld dynamometry (handgrip strength)

EXPERIMENTAL

All included patients will have a blinded evaluation of handgrip strength before weaning process.

Procedure: Handheld dynamometry (handgrip strength)

Interventions

Handheld dynamometry (handgrip strength)PROCEDURE

Patients will perform handgrip strength dynamometry through holding the device in their dominant hand with the maximum strength, with standardized arm and body positions, as well as incentives

Handheld dynamometry (handgrip strength)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients
  • under mechanical ventilation for at least 48 hours
  • meeting readiness to wean criteria according to international guidelines
  • with social security
  • informed consent given by the patient or a proxy

You may not qualify if:

  • baseline pre existing rheumatologic or neurologic condition preventing the patient to use the tested device
  • confusion (as assessed by Confusion Assessment Method for the Intensive Care Unit )
  • Patients whose extubation is a terminal extubation, or with prior decision not to resort a reintubation in case of post-extubation respiratory distress.
  • known pregnancy
  • Inability to deliver clear patient information (language barrier without an interpreter, for example)
  • Participation in another intervention research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benjamin Sztrymf

Clamart, France

Location

Related Publications (1)

  • Cottereau G, Messika J, Megarbane B, Guerin L, da Silva D, Bornstain C, Santos M, Ricard JD, Sztrymf B. Handgrip strength to predict extubation outcome: a prospective multicenter trial. Ann Intensive Care. 2021 Oct 2;11(1):144. doi: 10.1186/s13613-021-00932-3.

    PMID: 34601639DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2016

First Posted

October 27, 2016

Study Start

January 17, 2017

Primary Completion

November 1, 2019

Study Completion

July 1, 2020

Last Updated

July 2, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)