Quantitative Heat Loss With Laminar Air Flow

January 5, 2018 updated by: The Cleveland Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heat loss
Time Frame: 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).
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 23, 2017

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (Estimate)

March 27, 2012

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12-217

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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