- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04406220
The Effect of Large Versus Small Clog Size on Emergency Response Time
The Effect of Large Versus Small Clog Size on Healthcare Professional Emergency Response Time: a Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Amsterdam, Netherlands, 1081 HV
- Amsterdam Umc, Location Vumc
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthcare workers aged 18 years or older.
Exclusion Criteria:
- Inability to run on clogs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Small clog size
|
Participants will be randomized to run in small clogs
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Active Comparator: Large clog size
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Participants will be randomized to run in large clogs
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to complete the running course
Time Frame: Follow-up until 60 minutes.
|
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.
|
Follow-up until 60 minutes.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: Follow-up until 60 minutes.
|
Follow-up until 60 minutes.
|
Time to complete the running course for specific subgroups: By gender, job function, level of fitness.
Time Frame: Follow-up until 60 minutes.
|
Follow-up until 60 minutes.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Paul Elbers, MD, PhD, Amsterdam Umc, Location Vumc
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-clog
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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