N/A
N=80
Perioperative Accuracy of the Raiing Wireless Axillary Thermometer
Major Surgery Under General Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT02756910 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Accuracy of iThermonitor in Surgical Patients — 0.14 celsius — p=<0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- iThermonitor (WT701) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Peking Union Medical College Hospital
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of iThermonitor in Surgical Patients |
0.14 | <0.05 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT02756910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.