Healthy
Conditions
Keywords
heat loss, laminar airflow, operating rooms
Brief 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.
Interventions
OTHERstandard airflow with forced air warming.
Subjects will lie on operating room bed with standard airflow and forced air warming.
OTHERlaminar airflow with surgical drapes
OTHERlaminar airflow with forced air warming
Subjects will lie on operating room bed with laminar airflow and forced air warming.
OTHERstandard airflow with surgical drapes
Subjects will lie on operating room bed with standard airflow on and surgical drapes surrounding bed.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| heat loss | 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). |
Countries
United States
Outcome results
None listed