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Trial registered on ANZCTR


Registration number
ACTRN12617001492347
Ethics application status
Approved
Date submitted
16/08/2017
Date registered
23/10/2017
Date last updated
23/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The incidence of inadvertent perioperative hypothermia
Scientific title
The incidence of inadvertent perioperative hypothermia in patients undergoing general anesthesia and an examination of risk factors
Secondary ID [1] 292666 0
None
Universal Trial Number (UTN)
U1111-1200-7719
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypothermia 304408 0
Condition category
Condition code
Anaesthesiology 303738 303738 0 0
Other anaesthesiology
Surgery 303739 303739 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The incidence of inadvertent perioperative hypothermia in patients undergoing general anesthesia. The duration of observation: from before patients entered the operating room to 15 minutes after patients were transfered to post anesthesia care unit.
Intervention code [1] 298903 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303107 0
Primary outcome is to determine the incidence of inadvertent intraoperative hypothermia, defined as core temperature <36°C at any time during the perioperative period. The core temperature is assumed to be that of tympanic membrane temperature, since tympanic membrane temperature is easily obtained and has been validated to reflect core temperature. Infrared tympanic thermometer is used for assessment (Genius 2, Mansfield, USA)
Timepoint [1] 303107 0
6 months
Secondary outcome [1] 337897 0
Identify possible correlations with perioperative hypothermia of risk factors such as age, sex, height, weight, preoperative fasting period, ASA physical condition score, habits, comorbidities, type and size of surgery, endoscopic surgery usage, duration of anesthesia and surgery, irrigation and infusion fluids, room temperature and humidity, active or passive heating usage.
Timepoint [1] 337897 0
6 months

Eligibility
Key inclusion criteria
Patients undergoing general anesthesia undergoing elective surgery which expected to last longer than 30 minutes of surgical intervention. The patients agreed to participate in the study and signed the consent form.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients on emergency operations,
Patients undergoing open heart surgery with routine temperature monitoring,
Patients with central fever due to cerebral trauma-epilepsy or acute hydrocephalus etc.,
Patients with thermoregulatory abnormality (such as malignant hyperthermia, neuroleptic malignant syndrome etc.),
Patients whose preoperative temperature measured from tympanic membrane below 36 ° C and above 37.8 ° C,
Patients with thyroid disorders,
Patients with tympanic membranous pathology,
ASA physical status score IV-V patients,
Patients who will be anesthetized except for inhalation anesthesia such as TIVA

Study design
Purpose
Natural history
Duration
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
According to similar studies in the literature, the required sample width as a result of power analysis, by using PASS 11 (Power and Sample Size, version 11, for Windows), was determined as at least 1372 individuals in total. In this case, the power of the test is expected to be approximately 85.16%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9151 0
Turkey
State/province [1] 9151 0
ANKARA

Funding & Sponsors
Funding source category [1] 297305 0
Hospital
Name [1] 297305 0
Atatürk Training and Research Hospital
Address [1] 297305 0
Atatürk Training and Research Hospital Yildirim Beyazit University Department of Anesthesiology Universiteler Street 06000 Bilkent ANKARA
Country [1] 297305 0
Turkey
Primary sponsor type
Individual
Name
Süleyman Sari
Address
Atatürk Training and Research Hospital Yildirim Beyazit University Department of Anesthesiology Universiteler Street 06000 Bilkent ANKARA
Country
Turkey
Secondary sponsor category [1] 296275 0
Individual
Name [1] 296275 0
Semsi Mustafa Aksoy
Address [1] 296275 0
Atatürk Training and Research Hospital Yildirim Beyazit University Department of Anesthesiology Universiteler Street 06000 Bilkent ANKARA
Country [1] 296275 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298409 0
Atatürk Training and Research Hospital Ethics Committee
Ethics committee address [1] 298409 0
Atatürk Training and Research Hospital Bilkent Universiteler street 06000 ANKARA
Ethics committee country [1] 298409 0
Turkey
Date submitted for ethics approval [1] 298409 0
01/01/2016
Approval date [1] 298409 0
20/01/2016
Ethics approval number [1] 298409 0
07

Summary
Brief summary
We determined the incidence of unintended perioperative hypothermia in patients undergoing general anesthesia and examined risk factors. 2015 patients were studied and the incidence of perioperative hypothermia was 78.6%. There was a statistically significant difference between the patients with and without hypothermia in terms of age and age group, body mass index (BMI), ASA classification and chronic disease status (p <0,05). The age and BMI of hypothermic patients were significantly higher than those without hypothermia. Patients with hypothermia who were older than 65 years, those with a BMI greater than 25 kg / m2 and any chronic disease were significantly higher than those without hypothermia. Patients with ASA-I had a significantly lower percentage of hypothermic patients. Percentage of those with grade 3 or 4 surgery, patients with endoscopic surgery, duration of anesthesia over 2 hours, infusion or irrigation amount greater than 1000 ml were significantly higher than those without hypothermia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76998 0
Dr Süleyman Sari
Address 76998 0
Atatürk Training and Research Hospital Yildirim Beyazit University Department of Anesthesiology Universiteler Street 06000 Bilkent
Country 76998 0
Turkey
Phone 76998 0
+90 505 2648850
Fax 76998 0
Email 76998 0
drsuleymansari@gmail.com
Contact person for public queries
Name 76999 0
Dr Süleyman Sari
Address 76999 0
Atatürk Training and Research Hospital Yildirim Beyazit University Department of Anesthesiology Universiteler Street 06000 Bilkent
Country 76999 0
Turkey
Phone 76999 0
+90 505 2648850
Fax 76999 0
Email 76999 0
drsuleymansari@gmail.com
Contact person for scientific queries
Name 77000 0
Dr Süleyman Sari
Address 77000 0
Atatürk Training and Research Hospital Yildirim Beyazit University Department of Anesthesiology Universiteler Street 06000 Bilkent
Country 77000 0
Turkey
Phone 77000 0
+90 505 2648850
Fax 77000 0
Email 77000 0
drsuleymansari@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary