ClothingNCT04406220
The Effect of Large Versus Small Clog Size on Emergency Response Time
A study testing Small clog size and Large clog size in people with Clothing and Occupational Injuries, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clothing, Occupational Injuries
- What is being tested?
- Small clog size and Large clog size
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Feb 2020to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare workers aged 18 years or older.
Who cannot join
- Inability to run on clogs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Small clog size, Large clog size
- Medical subject headings
- Occupational Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small clog sizeOther
Participants will be randomized to run in small clogs
Large clog sizeOther
Participants will be randomized to run in large clogs
| Study group | Role | What they receive |
|---|---|---|
| Small clog size | Active comparator | Not described Receives: Other: Small clog size |
| Large clog size | Active comparator | Not described Receives: Other: Large clog size |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Follow-up until 60 minutes.
Secondary outcomes (2)
Adverse events
Measured: Follow-up until 60 minutes.
Time to complete the running course for specific subgroups: By gender, job function, level of fitness.
Measured: Follow-up until 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start20 Feb 2020
- Primary completion30 Mar 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ClothingStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H.J.S. de Grooth, MD, Amsterdam UMC, location VUmc
- Investigators
- Paul Elbers, MD, PhD, Study chair, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406220
- Sponsor's protocol ID
- 2019-clog
- Status last verified
- May 2020
- First submitted
- 2 Mar 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32799180
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Large Versus Small Clog Size on Healthcare Professional Emergency Response Time: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04406220
- Acronym / sponsor ID
- 2019-clog
- Conditions
- Clothing, Occupational Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small clog size | Active comparator | Other: Small clog size |
| Large clog size | Active comparator | Other: Large clog size |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthcare workers aged 18 years or older.
Key exclusion criteria (1 listed)
- Inability to run on clogs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small clog sizeParticipants will be randomized to run in small clogs | Other | Small clog size |
| Large clog sizeParticipants will be randomized to run in large clogs | Other | Large clog size |
Primary outcome
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.
2 secondary outcomes
Adverse events
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Derived from this study: PubMed 32799180Elbers 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Elbers, MD, PhD study chair
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small clog size and Large clog size in people with Clothing and Occupational Injuries, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete the running course (time frame: Follow-up until 60 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04406220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.