Trial record 15 of 110 for:    Open Studies | "Hypothermia"

An Epidemiology Survey on the Incidence of Perioperative Hypothermia of Patients With General Anaesthesia in Beijing

This study is currently recruiting participants.
Verified July 2013 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01913041
First received: July 29, 2013
Last updated: August 5, 2013
Last verified: July 2013
  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 [Patient Registry]
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Months
Official Title: An Epidemiology Survey on the Incidence of Perioperative Hypothermia of Patients With General Anaesthesia in Beijing

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The incidence rate of perioperative hypothermia [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 800
Study Start Date: August 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Detailed Description:

The investigators study 800 patients from 24 hospitals who receive elective surgery under general anesthesia.Core body temperature is measured using infrared tympanic thermometer and at different times:upon the patient's arrival at the operating area,upon entrance in the operation room,at the start of anesthesia,every 15 minutes throughout the entire surgery,and entrance PACU. The investigators record the type and dosage of anesthesia drug,duration of surgery and anesthesia,operation room temperature,the mount of the infusion of intravenous fluids and blood at room temperature.

  Eligibility

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

Subjects who undergo for an elective surgery under general anaesthesia

Criteria

Inclusion Criteria:

  • Male or female, no limitation on age
  • Subject will undergo an elective surgery under 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 3 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01913041

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Jie YI, doctoral    +86 10 69152025    neyil@pumch.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Jie YI, doctoral Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01913041     History of Changes
Other Study ID Numbers: MDI0077
Study First Received: July 29, 2013
Last Updated: August 5, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014