Perioperative Accuracy of the Raiing Wireless Axillary Thermometer

NCT02756910 | Completed Results

• 1 other identifier: HS-1019
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Surgery Under General Anesthesia

Keywords

open abdominal surgery; anesthesia, general

Outcome Measures

Primary Outcomes (1)

• Accuracy of iThermonitor in Surgical Patients

  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.

  From 1 to 3 hours after induction of anesthesia

Study Arms (1)

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

Device: iThermonitor (WT701)

Interventions

iThermonitor (WT701) DEVICE

Continuously monitor the axillary temperature during surgery

Surgery Patients >1.5 Hrs

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult surgery patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Dept. of Anesthesiology, PUMCH

Beijing, 100730, China

Location

Related Publications (47)

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Results Point of Contact

• Title: Lijian Pei
• Organization: Peking Union Medical College Hospital

hazelbeijing@vip.163.com

＋86 10 69152020

Study Officials

• Lijian Pei, MD

  Associate Prof. of Dept. of Anesthesiology, PUMCH

  PRINCIPAL INVESTIGATOR

• Yuguang Huang, MD

  Chair of Dept. of Anesthesiology, PUMCH

  STUDY CHAIR

• Daniel I Sessler, MD

  Chair of Dept. of Outcomes Research, Anesthesiology Institute, Cleveland Clinic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 3, 2016
• First Posted: April 29, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 14, 2021
• Results First Posted: May 14, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)