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OpenTrials
Completed

NCT Number: NCT01564212

Quantitative Heat Loss With Laminar Air Flow

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard airflow with forced air warming.

Other

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

laminar airflow with surgical drapes

Other

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

laminar airflow with forced air warming

Other

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

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Mar 27, 2012
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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