Quantitative Heat Loss With Laminar Air Flow

NCT ID: NCT01564212

Last Updated: 2018-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2017-02-23

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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standard airflow and forced air warming

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

Group Type ACTIVE_COMPARATOR

standard airflow with forced air warming.

Intervention Type OTHER

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

laminar airflow with surgical drapes

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

Group Type ACTIVE_COMPARATOR

laminar airflow with surgical drapes

Intervention Type OTHER

laminar aiflow with forced air warming

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

Group Type ACTIVE_COMPARATOR

laminar airflow with forced air warming

Intervention Type OTHER

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

standard airflow with surgical drapes

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

Group Type ACTIVE_COMPARATOR

standard airflow with surgical drapes

Intervention Type OTHER

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

Interventions

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standard airflow with forced air warming.

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

Intervention Type OTHER

laminar airflow with surgical drapes

Intervention Type OTHER

laminar airflow with forced air warming

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

Intervention Type OTHER

standard airflow with surgical drapes

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

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Kurz, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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12-217

Identifier Type: -

Identifier Source: org_study_id

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