Status:

UNKNOWN

Multi-center Validation of a Hypothermia Prediction Mobile Application (APP)

Lead Sponsor:

Peking Union Medical College Hospital

Conditions:

Perioperative Hypothermia

Eligibility:

All Genders

18+ years

Brief Summary

There have been no fully validated tools for rapid screen of surgical patients at risk of intraoperative hypothermia. The aim of this study is to validate the performance of a previously established p...

Detailed Description

This is a multicenter, prospective, observational cohort study to validate the property of a previously established mobile application (APP) \[2\] for estimating risk of intraoperative hypothermia. Pa...

Eligibility Criteria

Inclusion

  • aged 18 years or older
  • undergoing elective operation with general anesthesia or combined with other anesthesia
  • operation is expected to last more than 40 minutes

Exclusion

  • central hyperthermia (e.g., cerebrovascular disease, traumatic brain injury, cerebral operation, epilepsy or acute hydrocephalus)
  • impaired thermoregulation (e.g., neuroleptic malignant syndrome, malignant hyperthermia, or known hyperthyroidism/hypothyroidism with current thyroid dysfunction
  • infectious fever
  • core temperature ≥38.5 ℃ attributable to other causes within 3 days before surgery
  • operation with induced hypothermia (e.g. cardiopulmonary bypass)
  • unsuited for infrared tympanic thermometry or axillary temperature monitoring
  • unwilling to give signed consent

Key Trial Info

Start Date :

May 25 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2023

Estimated Enrollment :

3000 Patients enrolled

Trial Details

Trial ID

NCT05333120

Start Date

May 25 2021

End Date

December 1 2023

Last Update

April 18 2022

Active Locations (1)

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1

Department of Anesthesiology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Multi-center Validation of a Hypothermia Prediction Mobile Application (APP) | DecenTrialz