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CompletedNCT02946502GRIPWEANUpdated Jul 2, 2020

Handgrip Strength Value in Predicting Mechanical Ventilation Weaning

An interventional study of Handheld dynamometry (handgrip strength) in Ventilator Weaning, Hand Strength and Respiration, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-02.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
261
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

Previous studies have evidenced that Intensive Care Unit acquired peripheral muscle weakness may lead to delayed mechanical ventilation weaning (i.e difficult or prolonged weaning according to guidelines). Nevertheless, no study has ever tested the association between handgrip strength and extubation outcome. The investigators have generated the hypothesis that ICU acquired weakness, as tested by handgrip strength might be associated with extubation outcome. The investigators have planned to include 240 patients. Handgrip strength will be monitored, along with a full muscular assessment through Medical Research Council score by the attending physiotherapist. Physicians in charge of the patients will be blinded to these values and the weaning protocol will continue according to guidelines.

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Conditions studied

  • Ventilator Weaning
  • Hand Strength
  • Respiration
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In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
261 participants (actual)

Study arms

  • Experimental
    Handheld dynamometry (handgrip strength)

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

    Procedure: Handheld dynamometry (handgrip strength)

Interventions

  • ProcedureHandheld dynamometry (handgrip strength)

    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

06

What researchers measure

Primary outcomes

  1. extubation outcome according to handgrip strength value

    Each mechanical ventilation weaning trial

    Time frame: 7 days

Secondary outcomes

  1. Association between handgrip strength and difficulty of weaning according to guidelines

    Each mechanical ventilation weaning trial

    Time frame: 7 days

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

    Each mechanical ventilation weaning trial

    Time frame: 7 days

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

    Each mechanical ventilation weaning trial

    Time frame: 7 days

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

    Each mechanical ventilation weaning trial

    Time frame: 7 days

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

    Each mechanical ventilation weaning trial

    Time frame: 7 days

  6. Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital length of stay

    Time frame: 18 months

  7. Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital survival

    Time frame: 18 months

07

Study locations

1 site
  • Benjamin Sztrymf
    Clamart, France
08

References and documents

Publications

  • 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. PubMed 34601639 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02946502
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Oct 27, 2016
Start date
Jan 17, 2017
Primary completion
Nov 2019
Completion
Jul 2020
Last update
Jul 2, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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