Ventilator WeaningGRIPWEANNCT02946502
Handgrip Strength Value in Predicting Mechanical Ventilation Weaning
A study testing Handheld dynamometry (handgrip strength) in people with Ventilator Weaning and Hand Strength, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Weaning, Hand Strength, Respiration
- What is being tested?
- Handheld dynamometry (handgrip strength)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2017to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Dominant Hand Held Dynamometry in Mechanical Ventilation Weaning: a Prospective, Multicenter Study
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.
- Conditions
- Ventilator Weaning, Hand Strength, Respiration
- Being tested
- Handheld dynamometry (handgrip strength)
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handheld dynamometry (handgrip strength)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Handheld dynamometry (handgrip strength) | Experimental | All included patients will have a blinded evaluation of handgrip strength before weaning process. Receives: Procedure: Handheld dynamometry (handgrip strength) |
What is being measured
The primary outcome is the main question the study is designed to answer.
extubation outcome according to handgrip strength value
Each mechanical ventilation weaning trial
Measured: 7 days
Secondary outcomes (7)
Association between handgrip strength and difficulty of weaning according to guidelines
Each mechanical ventilation weaning trial
Measured: 7 days
Association between handgrip strength and cough strength as assessed through peak expiratory flow evaluated with a portable spirometer
Each mechanical ventilation weaning trial
Measured: 7 days
Association between handgrip strength and maximal inspiratory strength during a brief inspiratory valve occlusion on the ventilator
Each mechanical ventilation weaning trial
Measured: 7 days
Association between handgrip strength and peripheral muscular strength evaluated by the Medical Research Council score
Each mechanical ventilation weaning trial
Measured: 7 days
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
Measured: 7 days
Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital length of stay
Measured: 18 months
Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital survival
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start17 Jan 2017
- Primary completionNov 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946502
- Sponsor's protocol ID
- P150948
- Acronym
- GRIPWEAN
- Status last verified
- Jul 2020
- First submitted
- 18 Oct 2016
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Dominant Hand Held Dynamometry in Mechanical Ventilation Weaning: a Prospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT02946502
- Acronym / sponsor ID
- GRIPWEAN / P150948
- Conditions
- Ventilator Weaning, Hand Strength, Respiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Jan 2017
- Primary completion
- Nov 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Handheld dynamometry (handgrip strength) | Experimental | Procedure: Handheld dynamometry (handgrip strength)All included patients will have a blinded evaluation of handgrip strength before weaning process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Handheld dynamometry (handgrip strength) |
Primary outcome
extubation outcome according to handgrip strength value
Time frame: 7 days
Each mechanical ventilation weaning trial
7 secondary outcomes
Association between handgrip strength and difficulty of weaning according to guidelines
Time frame: 7 days
Association between handgrip strength and cough strength as assessed through peak expiratory flow evaluated with a portable spirometer
Time frame: 7 days
Association between handgrip strength and maximal inspiratory strength during a brief inspiratory valve occlusion on the ventilator
Time frame: 7 days
Association between handgrip strength and peripheral muscular strength evaluated by the Medical Research Council score
Time frame: 7 days
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
Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital length of stay
Time frame: 18 months
Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital survival
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Derived from this study: PubMed 34601639Cottereau 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.
- Individual participant dataSharing planned: No
Related trials for Ventilator Weaning
Not yet recruitingObservational study
Diaphragm Ultrasound and Rapid Shallow Breathing Index for Predicting Extubation Success
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Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Recruiting
Shenfu Injection for the Prevention and Treatment of Ventilator Dependence in Mechanically Ventilated Patients
Ventilator-induced Diaphragm Dysfunction, Ventilator Dependence
Enrolling by invitation
Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning
Ventilated Patient in Intensive Care
Not yet recruitingObservational study
Comparison of Sarcopenia Index, Diaphragm Ultrasonography, and Traditional Weaning Parameters in Predicting Successful Weaning From Mechanical Ventilation
Ventilator Weaning, Sarcopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handheld dynamometry (handgrip strength) in people with Ventilator Weaning and Hand Strength, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
extubation outcome according to handgrip strength value (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02946502, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.