Trial Outcomes & Findings for Perioperative Accuracy of the Raiing Wireless Axillary Thermometer (NCT NCT02756910)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

80 participants

Primary outcome timeframe

From 1 to 3 hours after induction of anesthesia

Results posted on

2021-05-14

Participant Flow

Participant milestones

Participant milestones
Measure	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 iThermonitor (WT701): Continuously monitor the axillary temperature during surgery
Overall Study STARTED	80
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Perioperative Accuracy of the Raiing Wireless Axillary Thermometer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgery Patients >1.5 Hrs n=80 Participants Use esophageal catheter for core temperature monitoring, Foley catheter for bladder temperature monitoring, and iThermonitor (WT701) for axillary temperature monitoring iThermonitor (WT701): Continuously monitor the axillary temperature during surgery
Age, Continuous	55 years STANDARD_DEVIATION 11 • n=99 Participants
Sex: Female, Male Female	35 Participants n=99 Participants
Sex: Female, Male Male	45 Participants n=99 Participants

PRIMARY outcome

Timeframe: From 1 to 3 hours after induction of anesthesia

Population: There were a total of 3,339 sets of iThermonitor and reference measurements from 80 patients (42 sets per patient on average). The iThermonitor temperature and the reference esophageal temperature agreed well overall. The iThermonitor temperatures ranged from 34.7 to 38.3°C, while the esophageal core temperatures ranged from 34.6 to 37.9°C

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.

Outcome measures

Outcome measures
Measure	Surgery Patients >1.5 Hrs n=80 Participants Use esophageal catheter for core temperature monitoring, Foley catheter for bladder temperature monitoring, and iThermonitor (WT701) for axillary temperature monitoring iThermonitor (WT701): Continuously monitor the axillary temperature during surgery
Accuracy of iThermonitor in Surgical Patients	0.14 celsius Standard Deviation 0.26

Adverse Events

Surgery Patients >1.5 Hrs

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lijian Pei

Peking Union Medical College Hospital

Phone: ＋86 10 69152020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place