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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard airflow and forced air warming | Active Comparator | Subjects will lie on operating room bed with standard airflow and forced air warming. |
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| laminar airflow with surgical drapes | Active Comparator | Subjects will lie on operating room bed with laminar airflow device on and surgical drapes surrounding bed. |
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| laminar aiflow with forced air warming | Active Comparator | Subjects will lie on operating room bed with laminar airflow on and warming forced air. |
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| standard airflow with surgical drapes | Active Comparator | Subjects will lie on operating room bed with standard airflow and surgical drapes surrounding bed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard airflow with forced air warming. | Other | Subjects will lie on operating room bed with standard airflow and forced air warming. |
|
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Kurz, M.D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D058636 | Surgical Drapes |
| ID | Term |
|---|---|
| D001512 | Bedding and Linens |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D013523 | Surgical Equipment |
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| laminar airflow with surgical drapes | Other |
|
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| laminar airflow with forced air warming | Other | Subjects will lie on operating room bed with laminar airflow and forced air warming. |
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| standard airflow with surgical drapes | Other | Subjects will lie on operating room bed with standard airflow on and surgical drapes surrounding bed. |
|