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Status unknownNCT02211703Updated Aug 7, 2014

National Epidemiologic Survey on the Incidence of Perioperative Hypothermia

An observational study in Hypothermia, sponsored by Jie YI. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-07.

Sponsored by Jie YI · Observational

The sponsor has not verified this record recently (last verified Aug 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,208
Ages
18 Years and older
Sex
All
01

Study summary

Study Objective:

  • to project the incidence of perioperative hypothermia in patients with elective surgery under general anesthesia in China
  • to determine the risk factors associated with perioperative hypothermia.
  • to explore the patient outcome of hypothermia such as cardiovascular events, wound infection,hospital stay and so on.

Study Design: The present study is a cross-sectional study with 30-day follow-up period.

Read the detailed description

This survey was anticipated to enroll 2208 patients with elective surgery under general anesthesia from 28 hospitals or so in China. 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 will be monitored at the following time points respectively: Arriving at waiting area, entering the OR room, 5 min before and after anesthesia induction, every 15 min during the operation, after 2h the tympanic temperature will be monitored at every 30 min, Tympanic temperature will also be taken when the surgery complete and when patients arrived at PACU. Other information will also be collected including the type and dosage of anesthesia drug,duration of surgery and anesthesia, patient warming method,operation room temperature, the amount of the infusion of intravenous fluids and blood and their warming techniques during the whole operation procedure. The postoperative follow-up will be conducted and recorded within 30 days after operation(for implantation surgery, the follow-up will be conducted within 90 days postoperatively ) which includes ICU stays, hospital stays, wound infection, new cardiovascular events.etc.

The contract research organization will be delegated to do an on site monitor once a month (online 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 conducted through the whole survey procedure. In order to guarantee the validation of the data, two data managing staffs will input and verify the data independently.

Statistical analysis software (SAS9.2) 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.

02

Conditions studied

  • Hypothermia

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Keywords

  • perioperative hypothermia
  • Epidemiology
  • Tympanic temperature
03

In context

Hypothermia

499 studies on the registry are indexed under Hypothermia; 54 are open to participants now.

This study's planned enrollment of 2,208 is above the median of 97 across 126 observational studies indexed under Hypothermia.

Browse Hypothermia studies →

Lead sponsor

Jie YI is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with elective operation under general anesthesia

Inclusion criteria

  • Male or female,age≥18 Subjects will undergo an elective surgeries with general anaesthesia The duration of operation is expected to be over 60 minutes The subjects agreed to participate in the study and signed the consent form.

Exclusion criteria

Exclusion Criteria:

  • Central high fever, 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 Temperature is higher than 37.8℃ within 3 days before surgery Diseases or surgery that may lead to inaccuracy in measurement of era thermometer , such as ear infection etc.

Surgeries with active cooling process during operation

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,208 participants (estimated)
Patient registry
No

Groups and cohorts

  • Observation

    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.

06

What researchers measure

Primary outcomes

  1. the incidence of perioperative hypothermia

    The core temperatures (tympanic membrane) will be measured at various time points to identify the occurence of hypothermia

    Time frame: from patients entered operating room to transfering to post anesthesia care units

Secondary outcomes

  1. record the postoperative adverse events

    To identify the hypothermia related adverse events, such as cardiovascular events, wound infection, hospital stays and so on.

    Time frame: From the day after operation to 30 days thereafter

07

Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02211703
Lead sponsor
Jie YI
Collaborators
Medical Consulting Center
Responsible party
Jie YI (Associate Professor, Peking Union Medical College Hospital) — Sponsor-investigator
First posted
Aug 7, 2014
Start date
Sep 2014
Primary completion
Oct 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Aug 7, 2014

Study contacts

Yuguang Huang, doctoral
principal investigator · Peking Union Medical College Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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