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Completed

NCT Number: NCT00980642

Accuracy of the Drager Dual-sensor Temperature Measurement System

Our primary hypothesis is that the Draeger dual-sensor temperature monitoring system, used at the forehead, is sufficiently accurate compared to tympanic, bladder or esophageal temperature and oral temperature for routine clinical use during hypothermic conditions, as well as during fever.

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Key information

Conditions

Hypothermia; Anesthesia Body Temperature Changes Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

We will include patients undergoing general anesthesia or regional anesthesia. The temperature recorded by Draeger dual-sensor monitoring system will be obtained at 5-minute interval.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing trauma surgery with general anesthesia
  • Patients undergoing orthopedic surgery with regional anesthesia

Exclusion criteria

  • Younger than 18 or older than 80 years of age
  • Have a pre-existing nasogastric tube
  • Require bispectral index monitoring
  • Upper esophageal disease
  • Forehead rash or infection
  • Oral infection or trauma
  • Ear infection or drainage

Treatment and study plan

Draeger double-sensor

Device

The sensor will be attached to the patient's forehead with adhesive tape, and a small amount of contact gel will be applied between sensor and skin.

Esophageal stethoscope temperature sensor

Device

Esophageal temperature is measured by sensors incorporated into an esophageal stethoscope during the surgery.

Foley catheter temperature sensor

Device

Urinary bladder temperature is measured via a sensor incorporated into a Foley catheter during the surgery

Primary outcomes

  1. The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature

    Time frame: From anesthesia induction to the end of surgery

    Determine if the Drager double-sensor temperature monitoring system, used at the forehead is accurate compared to esophageal temperature for general anesthesia group and bladder temperature for regional anesthesia group.

Secondary outcomes

  1. Sensitivity for Detection of Hypothermia

    Time frame: From anesthesia induction to the end of surgery

    Hypothermia is defined as a temperature < 36 Celsius degree

  2. Specificity for Detection of Hypothermia

    Time frame: From anesthesia induction to the end of surgery

    Hypothermia will be defined as a temperature < 36 Celsius degree

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Accuracy of the Draeger Dual-sensor Temperature Measurement System in The Perioperative Period

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 21, 2009
Registry last updated
Jun 14, 2017

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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