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An Epidemiology Survey on the Incidence of Perioperative Hypothermia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01913041
Recruitment Status : Completed
First Posted : July 31, 2013
Results First Posted : June 18, 2014
Last Update Posted : July 16, 2014
Sponsor:
Collaborators:
3M
Medical Consulting Center
Information provided by (Responsible Party):
Jie YI, Peking Union Medical College Hospital

Study Description
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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.

Condition or disease
Hypothermia

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.

Study Design
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Study Type : Observational
Actual Enrollment : 869 participants
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
Study Start Date : August 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Groups and Cohorts
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Group/Cohort
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.


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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913041


Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100000
Sponsors and Collaborators
Jie YI
3M
Medical Consulting Center
Investigators
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Principal Investigator: Yugung Huang, doctoral Peking Union Medical College Hospital
More Information
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Responsible Party: Jie YI, Associate Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01913041    
Other Study ID Numbers: MDI0077
First Posted: July 31, 2013    Key Record Dates
Results First Posted: June 18, 2014
Last Update Posted: July 16, 2014
Last Verified: July 2014
Keywords provided by Jie YI, Peking Union Medical College Hospital:
perioperative hypothermia
Epidemiology
Tympanic temperature
Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes