Perioperative Hypothermia Clinical Trial
— GAPOHIOfficial title:
National Epidemiology Survey on the Incidence of Perioperative Hypothermia in Patients With Elective Surgery Under General Anesthesia in Turkey
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.
Status | Active, not recruiting |
Enrollment | 3000 |
Est. completion date | June 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - 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 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 - 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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Turkish Society of Anesthesiology and Reanimation | Uludag University |
Doufas AG. Consequences of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):535-49. Review. — View Citation
Mahoney CB, Odom J. Maintaining intraoperative normothermia: a meta-analysis of outcomes with costs. AANA J. 1999 Apr;67(2):155-63. — View Citation
Sessler DI. Complications and treatment of mild hypothermia. Anesthesiology. 2001 Aug;95(2):531-43. Review. — View Citation
Smith JJ, Bland SA, Mullett S. Temperature--the forgotten vital sign. Accid Emerg Nurs. 2005 Oct;13(4):247-50. Epub 2005 Sep 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence rate of perioperative hypothermia in Turkey | 2 months | Yes | |
Secondary | The patient risk factors associated with perioperative hypothermia. | 2 months | Yes | |
Secondary | The surgery risk factors associated with perioperative hypothermia. | 2 months | Yes | |
Secondary | Complications related to perioperative hypothermia | 2 months | Yes | |
Secondary | Patient temperature management development strategies | 2 months | Yes |
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