Quantitative Heat Loss With Laminar Air Flow

NCT01564212 | Completed

• 1 other identifier: 12-217
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

heat loss; laminar airflow; operating rooms

Outcome Measures

Primary Outcomes (1)

• heat loss

  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).

  20 minutes

Study Arms (4)

standard airflow and forced air warming

ACTIVE COMPARATOR

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

Other: standard airflow with forced air warming.

laminar airflow with surgical drapes

ACTIVE COMPARATOR

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

Other: laminar airflow with surgical drapes

laminar aiflow with forced air warming

ACTIVE COMPARATOR

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

Other: laminar airflow with forced air warming

standard airflow with surgical drapes

ACTIVE COMPARATOR

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

Other: standard airflow with surgical drapes

Interventions

standard airflow with forced air warming. OTHER

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

standard airflow and forced air warming

laminar airflow with surgical drapes OTHER

Also known as: Subjects will lie on operating room bed with laminar airflow and surgical drapes surrounding bed.

laminar airflow with surgical drapes

laminar airflow with forced air warming OTHER

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

laminar aiflow with forced air warming

standard airflow with surgical drapes OTHER

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

standard airflow with surgical drapes

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Surgical Drapes

Intervention Hierarchy (Ancestors)

Bedding and Linens; Equipment and Supplies, Hospital; Equipment and Supplies; Surgical Equipment

Study Officials

• Andrea Kurz, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 27, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: February 23, 2017
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

US (1)