Ventilator Weaning Clinical Trial
— GRIPWEANOfficial title:
Prognostic Value of Dominant Hand Held Dynamometry in Mechanical Ventilation Weaning: a Prospective, Multicenter Study
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 |
Verified date | July 2020 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
France | Benjamin Sztrymf | Clamart |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
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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