The Effect of Large Versus Small Clog Size on Emergency Response Time

NCT04406220 | Completed

• 1 other identifier: 2019-clog
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Clothing; Occupational Injuries

Outcome Measures

Primary Outcomes (1)

• 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.

  Follow-up until 60 minutes.

Secondary Outcomes (2)

• Adverse events

  Follow-up until 60 minutes.

• Time to complete the running course for specific subgroups: By gender, job function, level of fitness.

  Follow-up until 60 minutes.

Study Arms (2)

Small clog size

ACTIVE COMPARATOR

Other: Small clog size

Large clog size

ACTIVE COMPARATOR

Other: Large clog size

Interventions

Small clog size OTHER

Participants will be randomized to run in small clogs

Small clog size

Large clog size OTHER

Participants will be randomized to run in large clogs

Large clog size

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthcare workers aged 18 years or older.

You may not qualify if:

• Inability to run on clogs.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC, location VUmc

Amsterdam, 1081 HV, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 32799180 DERIVED

MeSH Terms

Conditions

Occupational Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Paul Elbers, MD, PhD

  Amsterdam UMC, location VUmc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating investigator

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: May 28, 2020
• Study Start: February 20, 2020
• Primary Completion: March 30, 2020
• Study Completion: April 30, 2020
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

NL (1)