Quantitative Heat Loss With Laminar Air Flow

NeuroTherapia, Inc.

Status: Completed

Conditions: Healthy

Treatments: Other: laminar airflow with surgical drapes; Other: standard airflow with forced air warming.; Other: laminar airflow with forced air warming; Other: standard airflow with surgical drapes

Study type: Interventional

Funder types: Other

Identifiers

NCT01564212

12-217

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

10 participants in 4 patient groups

standard airflow and forced air warming

Active Comparator group

Description:

Subjects will lie on operating room bed with standard airflow and forced air warming.

Treatment:

Other: standard airflow with forced air warming.

laminar airflow with surgical drapes

Active Comparator group

Description:

Subjects will lie on operating room bed with laminar airflow device on and surgical drapes surrounding bed.

Treatment:

Other: laminar airflow with surgical drapes

laminar aiflow with forced air warming

Active Comparator group

Description:

Subjects will lie on operating room bed with laminar airflow on and warming forced air.

Treatment:

Other: laminar airflow with forced air warming

standard airflow with surgical drapes

Active Comparator group

Description:

Subjects will lie on operating room bed with standard airflow and surgical drapes surrounding bed.

Treatment:

Other: standard airflow with surgical drapes