Trial Outcomes & Findings for An Epidemiology Survey on the Incidence of Perioperative Hypothermia (NCT NCT01913041)

NCT ID: NCT01913041

Last Updated: 2014-07-16

Results Overview

Hypothermia incidence is defined as the percentage of the participants who occured hypothermia(Core temperature \<36℃) accounts for the total amount of participants.

• Recruitment status: COMPLETED
• Target enrollment: 869 participants
• Primary outcome timeframe: Perioperative period started from anesthesia induction to surgery ended
• Results posted on: 2014-07-16

Participant Flow

Dates of the recruitment period: From 2 Aug 2013 to 28 Nov 2013. Recruitment process: Random sample first and screening subjects according to the inclusion criteria and exclusion criteria, Assign ICF before enrollment.

Participant milestones

Measure	Investigation Group This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
Overall Study STARTED	869
Overall Study COMPLETED	830
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Measure	Investigation Group This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
Overall Study Protocol Violation	35
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	1

Baseline Characteristics

An Epidemiology Survey on the Incidence of Perioperative Hypothermia

Baseline characteristics by cohort

Measure	Investigation Group n=869 Participants This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
Age, Continuous	49.99 years STANDARD_DEVIATION 16.86 • n=5 Participants
Sex: Female, Male Female	347 Participants n=5 Participants
Sex: Female, Male Male	522 Participants n=5 Participants
Region of Enrollment China	869 participants n=5 Participants

PRIMARY outcome

Timeframe: Perioperative period started from anesthesia induction to surgery ended

Population: Actually 869 patients are enrolled, among which 39 patients were eliminated for the reasons operation cancelled temporarily or violate the eligible criteria, so 830 participants for analysis was determined to be analyzed per protocol in the end.

Hypothermia incidence is defined as the percentage of the participants who occured hypothermia(Core temperature <36℃) accounts for the total amount of participants.

Outcome measures

Measure	Investigation Group n=830 Participants This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
The Incidence of Perioperative Hypothermia	39.8 Percentage of hypothermia participants

Adverse Events

Observation Group

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

Dr. Jie Yi

Peking Union Medical College Hospital, Anesthesia Department

Phone: +86 10 69152025

Email: neyil@pumch.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60