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Quantitative Heat Loss With Laminar Air Flow

Sponsor
The Cleveland Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01564212
Collaborator
(none)
10
Enrollment
1
Location
4
Arms
59.8
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: standard airflow with forced air warming.
  • Other: laminar airflow with surgical drapes
  • Other: laminar airflow with forced air warming
  • Other: standard airflow with surgical drapes
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Feb 1, 2017
Actual Study Completion Date :
Feb 23, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: standard airflow and forced air warming

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

Other: standard airflow with forced air warming.
Subjects will lie on operating room bed with standard airflow and forced air warming.
Active Comparator: laminar airflow with surgical drapes

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

Other: laminar airflow with surgical drapes
Other Names:
  • Subjects will lie on operating room bed with laminar airflow and surgical drapes surrounding bed.

    		•
    Active Comparator: laminar aiflow with forced air warming

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

    Other: laminar airflow with forced air warming
    Subjects will lie on operating room bed with laminar airflow and forced air warming.
    Active Comparator: standard airflow with surgical drapes

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

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

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cleveland Clinic Foundation Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • The Cleveland Clinic

    Investigators

    • Principal Investigator: Andrea Kurz, M.D., The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT01564212
    Other Study ID Numbers:
    • 12-217
    First Posted:
    Mar 27, 2012
    Last Update Posted:
    Jan 9, 2018
    Last Verified:
    Jan 1, 2018
    Keywords provided by The Cleveland Clinic
    heat loss
    laminar airflow
    operating rooms

    Study Results

    No Results Posted as of Jan 9, 2018