Quantitative Heat Loss With Laminar Air Flow
This trial is active, not recruiting.
|Treatments||standard airflow with forced air warming., laminar airflow with surgical drapes, laminar airflow with forced air warming, standard airflow with surgical drapes|
|Sponsor||The Cleveland Clinic|
|Start date||March 2012|
|End date||September 2017|
|Trial size||10 participants|
|Trial identifier||NCT01564212, 12-217|
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.
|Intervention model||crossover assignment|
|Masking||single blind (outcomes assessor)|
|Primary purpose||supportive care|
time frame: 20 minutes
Male or female participants from 18 years up to 45 years old.
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
|Principal investigator||Andrea Kurz, M.D.|
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