Overview

This trial is active, not recruiting.

Condition healthy
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Active Comparator)
Subjects will lie on operating room bed with standard airflow and forced air warming.
standard airflow with forced air warming.
Subjects will lie on operating room bed with standard airflow and forced air warming.
(Active Comparator)
Subjects will lie on operating room bed with laminar airflow device on and surgical drapes surrounding bed.
laminar airflow with surgical drapes Subjects will lie on operating room bed with laminar airflow and surgical drapes surrounding bed.
(Active Comparator)
Subjects will lie on operating room bed with laminar airflow on and warming forced air.
laminar airflow with forced air warming
Subjects will lie on operating room bed with laminar airflow and forced air warming.
(Active Comparator)
Subjects will lie on operating room bed with standard airflow and surgical drapes surrounding bed.
standard airflow with surgical drapes
Subjects will lie on operating room bed with standard airflow on and surgical drapes surrounding bed.

Primary Outcomes

Measure
heat loss
time frame: 20 minutes

Eligibility Criteria

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

Additional Information

Principal investigator Andrea Kurz, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.