An Epidemiology Survey on the Incidence of Perioperative Hypothermia

This study has been completed.
Sponsor:
Collaborators:
3M
Medical Consulting Center
Information provided by (Responsible Party):
Jie YI, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01913041
First received: July 29, 2013
Last updated: July 2, 2014
Last verified: July 2014
  Purpose
  • 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.

Condition
Hypothermia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Epidemiology Survey on the Incidence of Perioperative Hypothermia of Patients Undergo Elective Operation With General Anaesthesia in Beijing Area

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • The Incidence of Perioperative Hypothermia [ Time Frame: Perioperative period started from anesthesia induction to surgery ended ] [ Designated as safety issue: Yes ]
    Hypothermia incidence is defined as the percentage of the participants who occured hypothermia(Core temperature <36℃) accounts for the total amount of participants.


Enrollment: 869
Study Start Date: August 2013
Study Completion Date: January 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

This survey was anticipated to enroll 800 patients who underwent elective operations with general anaesthesia from 24 hospitals in Peking. After obtaining approval from the Ethical Committee related to research involving human subjects,the investigators will enroll the patients according to the inclusion and exclusion criterion. The tympanic temperature(measured by Braun PRO4000 Thermometer) will be monitored at the following time points respectively: arrived at waiting area, enter the OR room, 5 min before and after anesthesia induction, every 15 min during the operation, operation ended,arrived at PACU. Other information will also be collected, the investigators will record the type and dosage of anesthesia drug,duration of surgery and anesthesia, the patient warming method or if it is used.operation room temperature,the amount of the infusion of intravenous fluids and blood,etc. during the whole operation procedure. The other information will be followed up and recorded after the operation(within 30 days postoperation) which incudes ICU stays, hospital stays, incision infection, new cardiology events.etc.

The contract research organization will be delegated to do the site monitor once a week for each hospital participate the survey during the recruitment and perform the source data validation at the same time to review the related medical records,source data and the case report forms, etc.to ensure the data accuracy and completeness

Data management will be conduct through the whole survey procedure. EPIDATA3.1 software was used for compile the inputting procedure for data inputting and management. In order to guarantee the correctness of the data, two data managing staffs should input and verify the data independently.

SAS9.2 statistical analysis software was used for the calculation of all the statistical analyses. The number of cases, mean, standard deviation, median value, maximal value and minimal value should be calculated for the descriptions of the qualitative parameters. Number of cases and percentages are used for the descriptions on the classification parameters.Two side test is used for all the statistical tests, P<0.05 indicates that the difference is statistically significant (unless indicated otherwise), and 95% confidence is used as the confidence interval.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who undergo elective surgery with general anaesthesia

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01913041

Locations
China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100000
Sponsors and Collaborators
Jie YI
3M
Medical Consulting Center
Investigators
Principal Investigator: Yugung Huang, doctoral Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Jie YI, Associate Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01913041     History of Changes
Other Study ID Numbers: MDI0077
Study First Received: July 29, 2013
Results First Received: May 16, 2014
Last Updated: July 2, 2014
Health Authority: China: Ethics Committee

Keywords provided by Peking Union Medical College Hospital:
perioperative hypothermia
Epidemiology
Tympanic temperature

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014