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NCT01564212 · ClinicalTrials.gov registry record · NA
Quantitative Heat Loss With Laminar Air Flow
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT01564212: Completed NA study, sponsored by The Cleveland Clinic.
NCT01564212 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01564212, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
With approval of the IRB at the Cleveland Clinic and written informed consent, the investigators propose to study up to 20 healthy volunteers in the protocol below as this will allow for drop-outs. As the investigators believe that 10 volunteers will provide sufficient power to detect clinically-meaningful differences between laminar air flow treatments. The study has been designed to find out whether heat loss increases significantly in laminar air flow operating rooms. Furthermore the investigators will find out whether active warming minimizes this heat loss. Increased heat loss increases the amount of perioperative hypothermia. It has been shown that perioperative hypothermia is associated with severe complications such as an increased incidence of surgical wound infections. On the other hand laminar air flow is explicitly used to decrease air-borne infections. Our study results will help to optimize thermal management of orthopedic patients.
Primary Outcome
Defining the within-volunteer difference in heat flux between laminar air flow 'on' and laminar air flow 'off' as the primary outcome of interest, we will use two linear regression models to perform analyses, respectively, for active warming and no active warming settings. Ambient temperature and relative humidity will be adjusted for within this linear model if they are not adequately balanced between the four experimental scenarios, on average (as determined by standard univariable summary sta
Interventions
- OTHER standard airflow with forced air warming.
- OTHER laminar airflow with surgical drapes
- OTHER laminar airflow with forced air warming
- OTHER standard airflow with surgical drapes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-03 |
| Est. Completion | 2017-02-23 |
| Phase | NA |
What the finished NCT01564212 record still lists
NCT01564212 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 4 interventions - of which standard airflow with forced air warming. is the first listed.
NCT01564212 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01564212 about?
NCT01564212 is a clinical study titled "Quantitative Heat Loss With Laminar Air Flow". With approval of the IRB at the Cleveland Clinic and written informed consent, the investigators propose to study up to 20 healthy volunteers in the protocol below as this will allow for drop-outs. As the investigators believe that 10 volunteers will provide sufficient power to detect clinically-mea...
What is the current status of trial NCT01564212?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2012-03. Estimated completion is 2017-02-23.
What interventions are being tested in trial NCT01564212?
The interventions under investigation include: standard airflow with forced air warming. (OTHER), laminar airflow with surgical drapes (OTHER), laminar airflow with forced air warming (OTHER), standard airflow with surgical drapes (OTHER).
Who is sponsoring clinical trial NCT01564212?
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 NCT01564212's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 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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