Incidence of Perioperative Hypothermia in Patients With Elective Surgery Under General Anesthesia in Turkey

NCT02736630 | Unknown DMC

• 1 other identifier: TurkishARD
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary objective of the study is to project the incidence rate of perioperative hypothermia under general anesthesia in patients who go under minimum 1 hour long elective surgery in at least 25 hospitals/medical centers in Turkey . Secondary objectives are to determine the patient risk factors associated with perioperative hypothermia, to determine the surgery risk factors associated with perioperative hypothermia, to determine the other risk factors associated with perioperative hypothermia, intraoperative infusion volume and effect of warming, intraoperative irrigation volume and effect of warming, intraoperative blood infusion volume and effect of warming, to determine complications related to perioperative hypothermia, to improve patient temperature management awareness and processes.

Conditions

Perioperative Hypothermia

Keywords

general anaesthesia; elective surgery; national epidemiology; turkey

Outcome Measures

Primary Outcomes (1)

• The incidence rate of perioperative hypothermia in Turkey

  2 months

Secondary Outcomes (4)

• The patient risk factors associated with perioperative hypothermia.

  2 months

• The surgery risk factors associated with perioperative hypothermia.

  2 months

• Complications related to perioperative hypothermia

  2 months

• Patient temperature management development strategies

  2 months

Interventions

body temperature OTHER

intermittant tympanic temperature measurement during surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing elective surgery under general anesthesia.

You may qualify if:

• Male or female, ≥18 years old
• Subject will undergo an elective surgery under general anesthesia
• The duration of surgery is expected to be over 60 minutes
• Patients or relatives whom the study is explained and their informed consent is documented
• Patients who are preplanned to be in ICU after surgery will not be excluded

You may not qualify if:

• 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
• Temperature is higher than 37.8 Celcius degree within 3 days before surgery
• Diseases or that may lead to inaccuracy in measurement, such as ear infection
• Therapeutic preoperative hypothermia
• Trauma related bleeding, shock and extensive fluid resuscitating surgeries
• Acute or chronic spine injury cases

Sponsors & Collaborators

• Turkish Society of Anesthesiology and Reanimation: lead
• Uludag University: collaborator

Related Publications (4)

• Smith JJ, Bland SA, Mullett S. Temperature--the forgotten vital sign. Accid Emerg Nurs. 2005 Oct;13(4):247-50. doi: 10.1016/j.aaen.2005.08.002. Epub 2005 Sep 30.

  PMID: 16199165 BACKGROUND

• Sessler DI. Complications and treatment of mild hypothermia. Anesthesiology. 2001 Aug;95(2):531-43. doi: 10.1097/00000542-200108000-00040. No abstract available.

  PMID: 11506130 BACKGROUND

• Doufas AG. Consequences of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):535-49. doi: 10.1016/s1521-6896(03)00052-1.

  PMID: 14661656 RESULT

• Mahoney CB, Odom J. Maintaining intraoperative normothermia: a meta-analysis of outcomes with costs. AANA J. 1999 Apr;67(2):155-63.

  PMID: 10488289 RESULT

MeSH Terms

Interventions

Body Temperature

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physiological Phenomena

Study Officials

• Hulya Bilgin, Prof

  Turkish Society of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 13, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 13, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share