Accuracy of the Drager Dual-sensor Temperature Measurement System
This study has been completed.
Sponsor:
Outcomes Research Consortium
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00980642
First received: September 18, 2009
Last updated: August 27, 2012
Last verified: August 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 18, 2009 | ||||||||
| Last Updated Date | August 27, 2012 | ||||||||
| Start Date ICMJE | March 2010 | ||||||||
| Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
1.Temperature as recorded by Draeger Dual-Sensor [ Time Frame: Day one ] [ Designated as safety issue: No ] 1.determine if the Drager dual-sensor temperature monitoring system, used at the forehead is accurate when compared to compared to tympanic, bladder, esophageal or oral temperatures. |
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| Original Primary Outcome Measures ICMJE |
1. To determine if the Drager dual-sensor temperature monitoring system, used at the forehead, is sufficiently accurate for routine clinical use during surgery and during post-anesthetic recovery [ Time Frame: During and post surgery ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT00980642 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE |
To evaluate whether commonly used systems are accurate for routine clinical use [ Time Frame: During and post-surgery ] [ Designated as safety issue: No ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Accuracy of the Drager Dual-sensor Temperature Measurement System | ||||||||
| Official Title ICMJE | Accuracy of the Draeger Dual-sensor Temperature Measurement System in The Perioperative Period | ||||||||
| Brief Summary | 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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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE | Fever | ||||||||
| Intervention ICMJE | Device: Draeger double sensor
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 75 | ||||||||
| Completion Date | August 2012 | ||||||||
| Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion: regional anesthesia (orthopedic, urology)
Exclusion: younger than 6 or older than 80 years of age
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| Gender | Both | ||||||||
| Ages | 6 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00980642 | ||||||||
| Other Study ID Numbers ICMJE | 08-453 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Andrea Kurz, M.D., Cleveland Clinic | ||||||||
| Study Sponsor ICMJE | Outcomes Research Consortium | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Outcomes Research Consortium | ||||||||
| Verification Date | August 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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