Perioperative Accuracy of the Raiing Wireless Axillary Thermometer

April 22, 2021 updated by: Lijian Pei, Peking Union Medical College Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Dept. of Anesthesiology, PUMCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult surgery patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Continuously monitor the axillary temperature during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From 1 to 3 hours after induction of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 3, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HS-1019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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