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NCT04511208 · ClinicalTrials.gov registry record · NA
Cooling Vest May Reduce Heat Stress During Surgery
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT04511208: Completed NA study, sponsored by The Cleveland Clinic.
NCT04511208 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04511208, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
The investigators will propose a randomized cross-over trial using a uniform and strongly balanced 4-period design in which will include four operations for each surgeon. Surgeons will be randomized to 1 of 4 sequences: ABBA, BAAB, AABB or BBAA. The design is "uniform" in that each treatment appears the same number of times within each sequence (uniform within sequence) and if each treatment appears the same number of times within each period (uniform within each period). It is strongly balanced with respect to first-order carryover effects because each treatment precedes every other treatment, including itself, the same number of times
Primary Outcome
Immediately after surgery, while still gowned, surgeons will rate their thermal comfort on a 0-10 Likert scale, with 0 representing extreme cold, 5 being thermal comfort, and 10 representing extreme heat. Two points on the 11-point Likert scale will be considered a clinically important difference.
Interventions
- DEVICE Cooling Vest
- DEVICE Without cooling vest
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-08-25 |
| Est. Completion | 2022-02-25 |
| Phase | NA |
What the finished NCT04511208 record still lists
NCT04511208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Cooling Vest is the first listed.
NCT04511208 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04511208 about?
NCT04511208 is a clinical study titled "Cooling Vest May Reduce Heat Stress During Surgery". The investigators will propose a randomized cross-over trial using a uniform and strongly balanced 4-period design in which will include four operations for each surgeon. Surgeons will be randomized to 1 of 4 sequences: ABBA, BAAB, AABB or BBAA. The design is "uniform" in that each treatment appears...
What is the current status of trial NCT04511208?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2020-08-25. Estimated completion is 2022-02-25.
What interventions are being tested in trial NCT04511208?
The interventions under investigation include: Cooling Vest (DEVICE), Without cooling vest (DEVICE).
Who is sponsoring clinical trial NCT04511208?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04511208's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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