Plain English Summary
Background and study aims
Peripheral muscle weakness is common in critically ill patients with mechanical ventilator. Evidence from previous studies showed that peripheral muscle strength is associated with weaning outcome. However, the predictive value of peripheral muscle strength on extubation outcome from mechanical ventilation has not been investigated. The purpose of this study was to evaluate the relationship between peripheral muscle strength and extubation failure among patients in an intensive care unit (ICU).
Who can participate?
ICU patients who are mechanically ventilated for more than 48 hrs and planning to wean according to standard protocol can participate.
What does the study involve?
Evaluation of the patient's biceps and quadriceps muscle strength
What are the possible benefits and risks of participating?
Benefits: We use peripheral muscle strength to predict patient extubation outcome. It might help the patient to decrease the extubation failure rate.
Risks: Maybe when the patient performs maximum isometric contraction, the blood pressure will increase. However, if the patient can not tolerate the test, we will stop the test and keep follow the patient's vital sign until stable
Where is the study run from?
Landseed International Hospital, Taoyuan City, Taiwan
When is the study starting and how long is it expected to run for?
July 2019 to June 2020
Who is funding the study?
Landseed International Hospital, Taiwan
Who is the main contact?
Dr Tsung-Hsien Wang
wth75529@gmail.com
Trial website
Contact information
Type
Public
Primary contact
Dr Tsung-Hsien Wang
ORCID ID
http://orcid.org/0000-0001-5096-1131
Contact details
Landseed International Hospital
No.77 Guangtai Road
Pingzhen District
Taoyuan City
32449
Taiwan
+886 (0)3 4945353
wangth@landseed.com.tw
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Peripheral muscle strength at the time of extubation may be a valuable predictor for extubation outcome
Acronym
Study hypothesis
Peripheral muscle strength at the time of extubation may be a valuable predictor for extubation outcome
Ethics approval
Approved 02/05/2019, Landseed International Hospital ethics institutional research committee (Pingzhen District Taoyuan City Guangtai Road 77, Taiwan), ref: IRB-19-017
Study design
Prospective observational study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
No participant information sheet available
Condition
Mechanical ventilation
Intervention
ICU patients who were mechanically ventilated for more than 48 hrs and were planning to wean according to standard protocol were enrolled in this study. Limb muscle strength was assessed using the hand-held dynamometer (MicroFET) on the day of planned extubation.
The MicroFET (Fet stands for Force Evaluating & Testing) is an electronic hand-held dynamometer which fits perfectly in the palm of the hand. It is the most cost effective and ergonomically designed hand-held dynamometer which is available on the market. It was designed to be a standalone gauge for capturing individual force measurements for any muscle test.
For testing isometric quadriceps femoris muscle force, the patient was placed in semi-Fowler position with knee extension and the transducer was placed on the anterior surface of the lower leg proximal to the ankle.
For testing isometric biceps muscle force, the patient was placed in semi-Fowler position with elbow slight flexion and the transducer was placed on the anterior surface of the wrist.
Examiners demonstrated and verbally explained the task before testing. Instruction and encouragement were given to have the patient gradually apply maximum force against the transducer pad of the microFET2 over three seconds. At least three repetitions were performed until results were reproducible.
Follow-up continued until the patient was transferred to the general ward.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Limb muscle strength assessed using the hand-held dynamometer (MicroFET) on the day of planned extubation.
2. Extubation failure rate, defined as the need for reintubation within 72 hours after extubation (determined by the attending physician observation)
3. Extubation rate (calculated as extubation failure participants divided by all participants)
Secondary outcome measures
1. In-hospital mortality defined as death occurring during the hospital stay
Overall trial start date
01/05/2019
Overall trial end date
30/06/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
ICU patients who were mechanically ventilated for more than 48 hrs and were planning to wean according to standard protocol
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Brain death
2. Ventilator dependent
3. Tracheostomy
4. Patients unable to perform the test were excluded (any rheumatologic conditions, previously known abnormal limitations of strength, amputations, muscular disease)
Recruitment start date
01/07/2019
Recruitment end date
30/06/2020
Locations
Countries of recruitment
Taiwan
Trial participating centre
Landseed International Hospital
Departments of Critical Care Medicine
No. 77 Guangtai Road
Pingzhen District
Taoyuan City
32449
Taiwan
Sponsor information
Organisation
Landseed International Hospital
Sponsor details
No.77
Guangtai Road
Pingzhen District
Taoyuan City
23449
Taiwan
+886 (0)3 4941234
wth75529@gmail.com
Sponsor type
Not defined
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Landseed International Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
30/12/2020
Participant level data
Available on request
Basic results (scientific)
Publication list