- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01564212
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-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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 to 45 years of age
- Healthy male and female volunteers
- ASA physical status I
- Capable and willing to provide written informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: standard airflow and forced air warming
Subjects will lie on operating room bed with standard airflow and forced air warming.
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Subjects will lie on operating room bed with standard airflow and forced air warming.
|
Active Comparator: laminar airflow with surgical drapes
Subjects will lie on operating room bed with laminar airflow device on and surgical drapes surrounding bed.
|
Other Names:
|
Active Comparator: laminar aiflow with forced air warming
Subjects will lie on operating room bed with laminar airflow on and warming forced air.
|
Subjects will lie on operating room bed with laminar airflow and forced air warming.
|
Active Comparator: standard airflow with surgical drapes
Subjects will lie on operating room bed with standard airflow and surgical drapes surrounding bed.
|
Subjects will lie on operating room bed with standard airflow on and surgical drapes surrounding bed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
heat loss
Time Frame: 20 minutes
|
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 statistics).
|
20 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrea Kurz, M.D., The Cleveland Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 12-217
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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