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| Name | Class |
|---|---|
| 3M | INDUSTRY |
| Medical Consulting Center | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who undergo elective surgery with general anaesthesia
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| Name | Affiliation | Role |
|---|---|---|
| Yugung Huang, doctoral | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100000 | China |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
39 patients were eliminated for the reasons operation cancelled temporarily or volate the eligible criteria, so 830 participants for analysis was determined in the end.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | Percentage of hypothermia participants | Perioperative period started from anesthesia induction to surgery ended |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observation Group | There is only one group, The main purpose of this investigation is to observe the hypothermia rate in elective operations under general anaesthesia in Peking in China. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jie Yi | Peking Union Medical College Hospital, Anesthesia Department | +86 10 69152025 | neyil@pumch.cn |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 869 |
| 0 |
| 869 |
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