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
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
Public
No.452, Huanqiu Rd
Luzhu District
Kaohsiung City
82144
Taiwan
 ORCID ID |
0000-0001-5096-1131 |
|---|---|
| Phone | +886 912-956-122 |
| wth75529@gmail.com |
Study information
| Study design | Prospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | No participant information sheet available |
| Scientific title | Peripheral muscle strength at the time of extubation may be a valuable predictor for extubation outcome |
| Study objectives | Peripheral 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) studied | 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 |
| 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 study start date | 01/05/2019 |
| Completion date | 30/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 52 |
| Key inclusion criteria | ICU patients who were mechanically ventilated for more than 48 hrs and were planning to wean according to standard protocol |
| Key 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) |
| Date of first enrolment | 01/07/2019 |
| Date of final enrolment | 30/06/2020 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
No. 77 Guangtai Road
Pingzhen District
Taoyuan City
32449
Taiwan
Sponsor information
Not defined
No.77
Guangtai Road
Pingzhen District
Taoyuan City
23449
Taiwan
| Phone | +886 (0)3 4941234 |
|---|---|
| wth75529@gmail.com | |
| Website | https://ssl.landseed.com.tw/lishin/index.php |
"ROR" |
https://ror.org/006arvw77 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The 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
