National Epidemiologic Survey on the Incidence of Perioperative Hypothermia

NCT02211703 | Unknown

• 1 other identifier: MDI0091
• Study Type: observational
• Target: 2,208
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypothermia

Keywords

perioperative hypothermia; Epidemiology; Tympanic temperature

Outcome Measures

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

  from patients entered operating room to transfering to post anesthesia care units

Secondary Outcomes (1)

• record the postoperative adverse events

  From the day after operation to 30 days thereafter

Study Arms (1)

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.

Eligibility Criteria

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

Study Population

patients with elective operation under general anesthesia

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jie YI: lead
• Medical Consulting Center: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

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

Study Officials

• Yuguang Huang, doctoral

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

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: August 6, 2014
• First Posted: August 7, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 7, 2014

Record last verified: 2014-08

Locations

CN (1)