An Epidemiology Survey on the Incidence of Perioperative Hypothermia

NCT01913041 | Completed Results DMC

• 1 other identifier: MDI0077
• Study Type: observational
• Target: 869
• Locations: 1 country
• Sites: 1

Brief Summary

• The purpose of this study is to understand and grasp the incidence rate of hypothermia during perioperative period of elective operations under general anaesthesia in Beijing.
• The purpose of this study is to carry out a subgroup analysis on the survey data and explore the high-risk factors for the incidence of hypothermia.

Conditions

Hypothermia

Keywords

perioperative hypothermia; Epidemiology; Tympanic temperature

Outcome Measures

Primary Outcomes (1)

• The Incidence of Perioperative Hypothermia

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

  Perioperative period started from anesthesia induction to surgery ended

Study Arms (1)

Investigation

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who undergo elective surgery with general anaesthesia

You may qualify if:

• Male or female, no limitation on age
• Subject who will undergo elective surgery with general anaesthesia
• The duration of surgery is expected to be over 40 minutes
• The subject agreed to participate in the study and signed the informed

You may not qualify if:

• Central high fever caused by enter nerves system disease or condition, including that induced by cerebrovascular disease, cerebral trauma, cerebral surgeries, epilepsy and acute hydrocephalus
• Thermoregulation abnormalities including malignant hyperthermia (MHS) and neuroleptic malignant syndrome, hypothyroidism or hyperthyroidism diagnosed by substantial evidence
• Infectious fever
• Patients whose core temperature is higher than 38.5°C within 7 days before surgery
• Diseases or that may lead to inaccuracy in measurement, such as ear infection
• Surgeries with active cooling process during operation

Sponsors & Collaborators

• Jie YI: lead
• 3M: collaborator
• Medical Consulting Center: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

In this study some information can hardly be completely collected such as wound infection incidence within 30 days postoperation, so further intervention study is needed to explore the relationship between hyperthermia and the potential complication.

Results Point of Contact

• Title: Dr. Jie Yi
• Organization: Peking Union Medical College Hospital, Anesthesia Department

neyil@pumch.cn

+86 10 69152025

Study Officials

• Yugung Huang, doctoral

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: July 31, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: January 1, 2014
• Last Updated: July 16, 2014
• Results First Posted: June 18, 2014

Record last verified: 2014-07

Locations

CN (1)