Quantitative Heat Loss With Laminar Air Flow

Completed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01564212

Run by

The Cleveland Clinic

People needed

10

Starts

2012-03-01

Expected to finish

2017-02-23

Last updated by the study team

2018-01-09

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 to 45 years of age
• Healthy male and female volunteers
• ASA physical status I
• Capable and willing to provide written informed consent

Where it is running

• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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