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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02946502
Other study ID # P150948
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 17, 2017
Est. completion date July 2020

Study information

Verified date July 2020
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 261
Est. completion date July 2020
Est. primary completion date November 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Benjamin Sztrymf Clamart

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary extubation outcome according to handgrip strength value Each mechanical ventilation weaning trial 7 days
Secondary Association between handgrip strength and difficulty of weaning according to guidelines Each mechanical ventilation weaning trial 7 days
Secondary Association between handgrip strength and cough strength as assessed through peak expiratory flow evaluated with a portable spirometer Each mechanical ventilation weaning trial 7 days
Secondary Association between handgrip strength and maximal inspiratory strength during a brief inspiratory valve occlusion on the ventilator Each mechanical ventilation weaning trial 7 days
Secondary Association between handgrip strength and peripheral muscular strength evaluated by the Medical Research Council score Each mechanical ventilation weaning trial 7 days
Secondary 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 7 days
Secondary Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital length of stay 18 months
Secondary Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital survival 18 months
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