Quantitative Heat Loss With Laminar Air Flow

Study Overview
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Brief Summary
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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.

Conditions
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Healthy

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard airflow and forced air warming<br>Subjects will lie on operating room bed with standard airflow and forced air warming. | Other: standard airflow with forced air warming.<br>* Subjects will lie on operating room bed with standard airflow and forced air warming.<br>|
| Active Comparator: laminar airflow with surgical drapes<br>Subjects will lie on operating room bed with laminar airflow device on and surgical drapes surrounding bed. | Other: laminar airflow with surgical drapes<br> <br> * Other names: Subjects will lie on operating room bed with laminar airflow and surgical drapes surrounding bed.;|
| Active Comparator: laminar aiflow with forced air warming<br>Subjects will lie on operating room bed with laminar airflow on and warming forced air. | Other: laminar airflow with forced air warming<br>* Subjects will lie on operating room bed with laminar airflow and forced air warming.<br>|
| Active Comparator: standard airflow with surgical drapes<br>Subjects will lie on operating room bed with standard airflow and surgical drapes surrounding bed. | Other: standard airflow with surgical drapes<br>* Subjects will lie on operating room bed with standard airflow on and surgical drapes surrounding bed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heat loss | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heat loss, laminar airflow, operating rooms