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Trial record 46 of 10351 for:    strength

Handgrip Strength Value in Predicting Mechanical Ventilation Weaning (GRIPWEAN)

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ClinicalTrials.gov Identifier: NCT02946502
Recruitment Status : Active, not recruiting
First Posted : October 27, 2016
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Ventilator Weaning Hand Strength Respiration Procedure: Handheld dynamometry (handgrip strength) Not Applicable

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prognostic Value of Dominant Hand Held Dynamometry in Mechanical Ventilation Weaning: a Prospective, Multicenter Study
Study Start Date : January 17, 2017
Actual Primary Completion Date : November 2018
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: Handheld dynamometry (handgrip strength)
All included patients will have a blinded evaluation of handgrip strength before weaning process.
Procedure: Handheld 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




Primary Outcome Measures :
  1. extubation outcome according to handgrip strength value [ Time Frame: 7 days ]
    Each mechanical ventilation weaning trial


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946502


Locations
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France
Benjamin Sztrymf
Clamart, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02946502     History of Changes
Other Study ID Numbers: P150948
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No