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Completed

NCT Number: NCT02946502

Handgrip Strength Value in Predicting Mechanical Ventilation Weaning

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benjamin Sztrymf

Clamart, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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

Primary outcomes

  1. extubation outcome according to handgrip strength value

    Time frame: 7 days

    Each mechanical ventilation weaning trial

Secondary outcomes

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

    Time frame: 7 days

    Each mechanical ventilation weaning trial

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

    Time frame: 7 days

    Each mechanical ventilation weaning trial

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

    Time frame: 7 days

    Each mechanical ventilation weaning trial

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

    Time frame: 7 days

    Each mechanical ventilation weaning trial

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

    Time frame: 7 days

    Each mechanical ventilation weaning trial

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Prognostic Value of Dominant Hand Held Dynamometry in Mechanical Ventilation Weaning: a Prospective, Multicenter Study

Acronym: GRIPWEAN

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Oct 27, 2016
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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