Correlation between peripheral muscle strength and breathing tube removal outcome

ISRCTN ISRCTN16370134
DOI https://doi.org/10.1186/ISRCTN16370134
Submission date
01/05/2019
Registration date
30/05/2019
Last edited
10/08/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Tsung-Hsien Wang
Public

No.452, Huanqiu Rd
Luzhu District
Kaohsiung City
82144
Taiwan

ORCiD logoORCID ID 0000-0001-5096-1131
Phone +886 912-956-122
Email wth75529@gmail.com

Study information

Study designProspective observational study
Primary study designObservational
Secondary study designLongitudinal study
Study setting(s)Hospital
Study typeScreening
Participant information sheet No participant information sheet available
Scientific titlePeripheral muscle strength at the time of extubation may be a valuable predictor for extubation outcome
Study objectivesPeripheral muscle strength at the time of extubation may be a valuable predictor for extubation outcome
Ethics approval(s)Approved 02/05/2019, Landseed International Hospital ethics institutional research committee (Pingzhen District Taoyuan City Guangtai Road 77, Taiwan), ref: IRB-19-017
Health condition(s) or problem(s) studiedMechanical ventilation
InterventionICU 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 typeOther
Primary outcome measure1. 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 measures1. In-hospital mortality defined as death occurring during the hospital stay
Overall study start date01/05/2019
Completion date30/06/2020

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants60
Total final enrolment52
Key inclusion criteriaICU patients who were mechanically ventilated for more than 48 hrs and were planning to wean according to standard protocol
Key exclusion criteria1. 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)
Date of first enrolment01/07/2019
Date of final enrolment30/06/2020

Locations

Countries of recruitment

  • Taiwan

Study participating centre

Landseed International Hospital
Departments of Critical Care Medicine
No. 77 Guangtai Road
Pingzhen District
Taoyuan City
32449
Taiwan

Sponsor information

Landseed International Hospital
Not defined

No.77
Guangtai Road
Pingzhen District
Taoyuan City
23449
Taiwan

Phone +886 (0)3 4941234
Email wth75529@gmail.com
Website https://ssl.landseed.com.tw/lishin/index.php
ROR logo "ROR" https://ror.org/006arvw77

Funders

Funder type

Hospital/treatment centre

Landseed International Hospital

No information available

Results and Publications

Intention to publish date30/12/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 09/08/2021 10/08/2021 Yes No

Editorial Notes

10/08/2021: Publication reference added.
03/06/2021: The intention to publish date has been changed from 30/12/2020 to 30/12/2022
02/06/2021: Total final enrolment number added.
06/01/2021: The public contact's details have ben changed.
31/05/2019: Internal review.
29/05/2019: Trial’s existence confirmed by Lianxin International Hospital Human Test Committee