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Perioperative Accuracy of the Raiing Wireless Axillary Thermometer

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ClinicalTrials.gov Identifier: NCT02756910
Recruitment Status : Unknown
Verified May 2016 by Lijian Pei, Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : April 29, 2016
Last Update Posted : May 11, 2016
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Lijian Pei, Peking Union Medical College Hospital

Tracking Information
First Submitted Date April 3, 2016
First Posted Date April 29, 2016
Last Update Posted Date May 11, 2016
Study Start Date May 2016
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 9, 2016)
Accuracy of iThermonitor in surgical patients [ Time Frame: From 1 to 3 hours after induction of anesthesia ]
Accuracy, defined as the true difference between reference and iThermonitor temperature. The esophageal temperature will be the core temperature reference during surgery. The primary outcome measure is the proportion of iThermonitor measurements for a patient that are within 0.5° C of the reference will be calculated, and this proportion (median, quartiles, 95% CI) will be summarized across patients. The Secondary outcome measure are bias and 95% CIs determined by repeated-measures Bland-Altman analysis. For each patient the average difference between the iThermometer and the reference temperature will be calculated. Patient iThermonitor measurements will be regressed on patient reference measurements to assess the Pearson correlation and 95% CI between iThermonitor and reference and to estimate the bias (slope) of device versus reference.
Original Primary Outcome Measures
 (submitted: April 27, 2016)
Accuracy of iThermonitor in surgical patients [ Time Frame: From 1 to 3 hours after induction of anesthesia ]
Accuracy, defined as the true difference between reference and iThermonitor temperature. The esophageal temperature will be the core temperature reference during surgery. For each patient the average difference between the iThermometer and the reference temperature will be calculated. Patient mean iThermonitor measurements will be regressed on patient mean reference measurements to assess the Pearson correlation and 95% CI between iThermonitor and reference and to estimate the bias (slope) of device versus reference. The proportion of iThermonitor measurements for a patient that are within 0.5° C of the reference will be calculated, and this proportion (median, quartiles, 95% CI) will be summarized across patients. Within-patient variability on the bias (i.e., reference measurement versus iThermonitor measurement) will be calculated as the SD within patient, and these will be summarized across patients with median (quartiles).
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Perioperative Accuracy of the Raiing Wireless Axillary Thermometer
Official Title Perioperative Accuracy of the Raiing Wireless Axillary Thermometer
Brief Summary

A new wireless axillary thermometer from Raiing Medical uses a proprietary system, iThermonitor (WT701), to provide better estimates of core temperature than a conventional axillary probe. Improvement results in part because the axillary probe measures and records temperatures continuously every 4 seconds and includes software to compensate for ambient temperature and positional changes including arm abduction.

Whether the iThermonitor is sufficiently accurate for clinical use remains unknown. The investigators thus propose to evaluate the system in perioperative patients who often experience thermal perturbations over a range of several °C. Specifically, the investigators propose to determine the precision and accuracy of iThermonitor in surgical patients and during the initial hour of recovery. As in previous studies, the investigators will consider the thermometer sufficiently accurate for clinical use if most Raiing temperatures are within ±0.5°C of the reference temperature.

Detailed Description

Patient characteristics, including age, height, weight, sex, and ASA status, and details of the surgery, including procedure and postoperative diagnosis will be recorded. The investigator will record the time of anesthesia induction and emergence. At 10-minute intervals during surgery, the investigator will record inspired volatile anesthetic concentration, mean-arterial pressure, type of thermal management device(s), and urine output over the previous 10-minute interval.

After induction of general anesthesia (without restriction as to type), the anesthesiologist will insert a temperature sensor into the distal esophagus. The distance will be determined by maximal heart sounds (if a stethoscope is used), or the probe will be inserted 0.48.(sitting height) - 4.4 cm. If an esophageal probe cannot be used, a thermometer can be inserted to between 10 and 20 cm into the nasopharynx. The surgical team will position a Foley catheter with temperature sensor into the urinary bladder. Ambient temperature will be recorded from an electronic probe situated at the height of the patients, well away from any heat-producing equipment.

Axillary temperature will be recorded by iThermonitor, a Raiing Medical wireless module, paired to an iPhone. An adhesive patch provided by Raiing will be used to securely position the Railing probe in a shaved axilla before the anesthesia induction. Patients will be asked to adduct the ipsilateral arm for up to 5 minutes after the probe is inserted, or until the temperature displayed on the paired iPhone is stable. Thereafter, patients will be free to move their arms.Monitored arm position during surgery will be recorded (arm tightly tucked, arm loose at side, arm abducted).

Temperatures will be recorded at 10-minute intervals during surgery and during the initial postoperative hour. Just before anesthetic emergence, the esophageal or nasopharyngeal thermometer will be removed, but the Foley catheter retained. The axillary device will then be removed after an hour of recovery, and the study concluded. The Foley catheter can be removed or retained per clinical need.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult surgery patients
Condition Major Surgery Under General Anesthesia
Intervention Device: iThermonitor (WT701)
Continuously monitor the axillary temperature during surgery
Study Groups/Cohorts Surgery Patients >1.5 Hrs
Use esophageal catheter for core temperature monitoring, Foley catheter for bladder temperature monitoring, and iThermonitor (WT701) for axillary temperature monitoring
Intervention: Device: iThermonitor (WT701)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 27, 2016)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • adults having an American Society of Anesthesiologists (ASA) physical status of 1-3
  • must be scheduled for surgery of the abdomen or pelvis that is expected to last 1.5-4 hours
  • require general endotracheal anesthesia and insertion of a Foley catheter

Exclusion Criteria:

  • patients in whom neither esophageal nor nasopharyngeal temperature monitoring is practical
  • patients in whom active intravenous infusion is required in both arms
  • patients who are allergic to hydrogel
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02756910
Other Study ID Numbers HS-1019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Lijian Pei, Peking Union Medical College Hospital
Study Sponsor Peking Union Medical College Hospital
Collaborators The Cleveland Clinic
Investigators
Principal Investigator: Lijian Pei, MD Associate Prof. of Dept. of Anesthesiology, PUMCH
Study Chair: Yuguang Huang, MD Chair of Dept. of Anesthesiology, PUMCH
Study Director: Daniel I Sessler, MD Chair of Dept. of Outcomes Research, Anesthesiology Institute, Cleveland Clinic
PRS Account Peking Union Medical College Hospital
Verification Date May 2016