Quantitative Heat Loss With Laminar Air Flow

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: laminar airflow with forced air warming; Other: standard airflow with forced air warming.; Other: laminar airflow with surgical drapes; Other: standard airflow with surgical drapes

• Registration Number: NCT01564212
• Lead Sponsor: The Cleveland Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-27
• Primary Completion: 2017-02
• Study Completion: 2017-02-23
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
laminar aiflow with forced air warming	laminar airflow with forced air warming	Subjects will lie on operating room bed with laminar airflow on and warming forced air.
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.
laminar airflow with surgical drapes	laminar airflow with surgical drapes	Subjects will lie on operating room bed with laminar airflow device on and surgical drapes surrounding bed.
standard airflow with surgical drapes	standard airflow with surgical drapes	Subjects will lie on operating room bed with standard airflow and surgical drapes surrounding bed.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States