Condition category
Not Applicable
Date applied
01/05/2019
Date assigned
30/05/2019
Last edited
31/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://ssl.landseed.com.tw/lishin/index.php

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

Publication citations

Additional files

Editorial Notes

31/05/2019: Internal review. 29/05/2019: Trial’s existence confirmed by Lianxin International Hospital Human Test Committee