Back to resultsThe Effect of Large Versus Small Clog Size on Emergency Response Time
Primary Purpose
Clothing, Occupational Injuries
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Small clog size
Large clog size
Sponsored by
About this trial
This is an interventional health services research trial for Clothing
Eligibility Criteria
Inclusion Criteria:
- Healthcare workers aged 18 years or older.
Exclusion Criteria:
- Inability to run on clogs.
Sites / Locations
- Amsterdam UMC, location VUmc
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Small clog size
Large clog size
Arm Description
Outcomes
Primary Outcome Measures
Time to complete the running course
The time to complete the course will be compared between the two groups using a linear model with the randomized allocation and the stratification variable as covariates.
Secondary Outcome Measures
Adverse events
Time to complete the running course for specific subgroups: By gender, job function, level of fitness.
Full Information
NCT ID
NCT04406220
First Posted
March 2, 2020
Last Updated
May 27, 2020
Sponsor
Amsterdam UMC, location VUmc
1. Study Identification
Unique Protocol Identification Number
NCT04406220
Brief Title
The Effect of Large Versus Small Clog Size on Emergency Response Time
Official Title
The Effect of Large Versus Small Clog Size on Healthcare Professional Emergency Response Time: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In many hospitals, clogs, usually white, are provided for healthcare workers. In our hospital, health care professionals from the department of intensive care medicine may be summoned to an emergency situation on a 24/7 basis. Clogs are thought to be of importance for running. Although clogs are available in several sizes, clog size is typically left to the discretion of the individual healthcare worker. Interestingly,
The primary goal of this randomized controlled trial is to assess if wearing large size clogs as compared to small size clogs results in increased running speed.
Participants will be randomized to small versus large clog size using a using randomly permuted blocks stratified by gender. Following randomization, participants will wear the clogs of allocated size and complete a standardized running course.
The primary endpoint is the time taken to complete the course.
The enrolment of 50 subjects would provide 80% power to show a 5-second difference in the response time at an average response time of 30 seconds with a 6 second standard deviation.
The ethical committee judged the study protocol exempt from extensive review.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clothing, Occupational Injuries
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Small clog size
Arm Type
Active Comparator
Arm Title
Large clog size
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Small clog size
Intervention Description
Participants will be randomized to run in small clogs
Intervention Type
Other
Intervention Name(s)
Large clog size
Intervention Description
Participants will be randomized to run in large clogs
Primary Outcome Measure Information:
Title
Time to complete the running course
Description
The time to complete the course will be compared between the two groups using a linear model with the randomized allocation and the stratification variable as covariates.
Time Frame
Follow-up until 60 minutes.
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
Follow-up until 60 minutes.
Title
Time to complete the running course for specific subgroups: By gender, job function, level of fitness.
Time Frame
Follow-up until 60 minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthcare workers aged 18 years or older.
Exclusion Criteria:
Inability to run on clogs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Elbers, MD, PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Study Chair
Facility Information:
Facility Name
Amsterdam UMC, location VUmc
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32799180
Citation
Elbers PWG, de Grooth HJ, Girbes ARJ. The effect of small versus large clog size on emergency response time: A randomized controlled trial. J Crit Care. 2020 Dec;60:116-119. doi: 10.1016/j.jcrc.2020.07.028. Epub 2020 Aug 8.
Results Reference
derived
Learn more about this trial
The Effect of Large Versus Small Clog Size on Emergency Response Time
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