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Quantitative Heat Loss With Laminar Air Flow

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ClinicalTrials.gov Identifier: NCT01564212
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Healthy 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 Not Applicable

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

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 Name: 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.




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564212


Locations
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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Andrea Kurz, M.D. The Cleveland Clinic
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01564212    
Other Study ID Numbers: 12-217
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Keywords provided by The Cleveland Clinic:
heat loss
laminar airflow
operating rooms