Perioperative HypothermiaGAPOHINCT02736630
Incidence of Perioperative Hypothermia in Patients With Elective Surgery Under General Anesthesia in Turkey
An observational study of Perioperative Hypothermia, run by Turkish Society of Anesthesiology and Reanimation.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Perioperative Hypothermia
- What is being tested?
- body temperature
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Jun 2016
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective surgery under general anesthesia.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official 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.
Read the detailed description
Mild hypothermia during perioperative period is very common, and the percentage accounts for about half of all patients undergoing operations, which is directly related to the following three major adverse events that significantly increase their risks: 1) cardiac complications, 2) hemorrhage, 3) infection complications , particularly in patients with high risk factors (ASA grade III, IV). Furthermore, the decrease in body temperature may also lead to the following situations: 1) prolongation in retention time in post-anesthetic ICU (PACU), 2) decrease in the thermal comfort for patients, and thus affecting the satisfaction degree of patients and increasing cost.
From the viewpoint of patient safety, body surface temperature is only a vital sign. Therefore, in order to prevent hypothermia during perioperative period, core temperature monitoring must be carried out from the very beginning of the operation. The heat loss during operations should be minimized. Active warming measurements should be taken for high risk patients during the entire procedures of operations.
Although the literature have reported high incidence rate of hypothermia during perioperative period of selective operations, there's no detailed information about perioperative hypothermia prevalence in Turkey. Actually there are only a few studies about patient warming effectiveness. A small scale study done by Kocaeli University in Turkey in 2013 shows the post operative hypothermia incidence as 45.7%. Another study and survey done by Cerrahpasa Medicine Faculty shows even among healthcare professionals there is great variance about the perception and results of hypothermia. Those facts drives investigators to gather more clinical evidence about perioperative hypothermia.
Under the supervision of Turkish Anesthesiology and Reanimation Society and coordination of Prof Dr Hulya Bilgin from Uludag University Medicine Faculty Anesthesiology and Reanimation Clinic it is aimed to gather evidence about hypothermia prevalence patients who go under minimum 1 hour elective surgery under general anesthesia. So with the results of such a study it is aimed to improve the standard protocols regarding patient temperature management, patient warming management and also to avoid the complications and costs related to hypothermia.
In order to further obtain information on the current status of temperature monitoring and perioperative warming practice in most parts of the country, to project incidence rate of perioperative hypothermia in most parts of the country, explore the relationship between perioperative hypothermia and postoperative clinical outcome, and to provide evidence for the improvement of perioperative body temperature management guidelines in accordance with characteristics of the current Turkish healthcare status, investigators will conduct surveys in department of anesthesiology over certain regions of Turkey to carry out a large scale prospective study. In the study, investigators will search the incidence rate of perioperative hypothermia in the surveyed areas, explore the causes of hypothermia, base on which it is expected to enable to project perioperative hypothermia incidence rate, to verify the effectiveness of perioperative hypothermia risk assessment questionnaire for patients under general anesthesia, and to provide guidance and evidence for the clinical practice of perioperative warming care.
- Conditions
- Perioperative Hypothermia
- Being tested
- body temperature
- Keywords
- general anaesthesia, elective surgery, national epidemiology, turkey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body temperatureOther
intermittant tympanic temperature measurement during surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of perioperative hypothermia in Turkey
Measured: 2 months
Secondary outcomes (4)
The patient risk factors associated with perioperative hypothermia.
Measured: 2 months
The surgery risk factors associated with perioperative hypothermia.
Measured: 2 months
Complications related to perioperative hypothermia
Measured: 2 months
Patient temperature management development strategies
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2016
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Perioperative HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Turkish Society of Anesthesiology and Reanimation
- Sponsor type
- University, hospital or other
- Collaborators
- Uludag University
- Responsible party
- Principal investigator, Hulya Bilgin, Turkish Society of Anesthesiology and Reanimation
- Investigators
- Hulya Bilgin, Prof, Principal investigator, Turkish Society of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736630
- Sponsor's protocol ID
- TurkishARD
- Acronym
- GAPOHI
- Status last verified
- Apr 2016
- First submitted
- 1 Apr 2016
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 16199165Sessler DI. Complications and treatment of mild hypothermia. Anesthesiology. 2001 Aug;95(2):531-43. doi: 10.1097/00000542-200108000-00040. No abstract available.
PubMed 11506130Doufas 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.
PubMed 14661656Mahoney CB, Odom J. Maintaining intraoperative normothermia: a meta-analysis of outcomes with costs. AANA J. 1999 Apr;67(2):155-63.
PubMed 10488289
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Epidemiology Survey on the Incidence of Perioperative Hypothermia in Patients With Elective Surgery Under General Anesthesia in Turkey
- ClinicalTrials.gov ID
- NCT02736630
- Acronym / sponsor ID
- GAPOHI / TurkishARD
- Conditions
- Perioperative Hypothermia
- Keywords
- general anaesthesia, elective surgery, national epidemiology, turkey
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Turkish Society of Anesthesiology and ReanimationUniversity, hospital or other
- Collaborators
- Uludag University
- Study start
- Mar 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mild hypothermia during perioperative period is very common, and the percentage accounts for about half of all patients undergoing operations, which is directly related to the following three major adverse events that significantly increase their risks: 1) cardiac complications, 2) hemorrhage, 3) infection complications , particularly in patients with high risk factors (ASA grade III, IV). Furthermore, the decrease in body temperature may also lead to the following situations: 1) prolongation in retention time in post-anesthetic ICU (PACU), 2) decrease in the thermal comfort for patients, and thus affecting the satisfaction degree of patients and increasing cost.
From the viewpoint of patient safety, body surface temperature is only a vital sign. Therefore, in order to prevent hypothermia during perioperative period, core temperature monitoring must be carried out from the very beginning of the operation. The heat loss during operations should be minimized. Active warming measurements should be taken for high risk patients during the entire procedures of operations.
Although the literature have reported high incidence rate of hypothermia during perioperative period of selective operations, there's no detailed information about perioperative hypothermia prevalence in Turkey. Actually there are only a few studies about patient warming effectiveness. A small scale study done by Kocaeli University in Turkey in 2013 shows the post operative hypothermia incidence as 45.7%. Another study and survey done by Cerrahpasa Medicine Faculty shows even among healthcare professionals there is great variance about the perception and results of hypothermia. Those facts drives investigators to gather more clinical evidence about perioperative hypothermia.
Under the supervision of Turkish Anesthesiology and Reanimation Society and coordination of Prof Dr Hulya Bilgin from Uludag University Medicine Faculty Anesthesiology and Reanimation Clinic it is aimed to gather evidence about hypothermia prevalence patients who go under minimum 1 hour elective surgery under general anesthesia. So with the results of such a study it is aimed to improve the standard protocols regarding patient temperature management, patient warming management and also to avoid the complications and costs related to hypothermia.
In order to further obtain information on the current status of temperature monitoring and perioperative warming practice in most parts of the country, to project incidence rate of perioperative hypothermia in most parts of the country, explore the relationship between perioperative hypothermia and postoperative clinical outcome, and to provide evidence for the improvement of perioperative body temperature management guidelines in accordance with characteristics of the current Turkish healthcare status, investigators will conduct surveys in department of anesthesiology over certain regions of Turkey to carry out a large scale prospective study. In the study, investigators will search the incidence rate of perioperative hypothermia in the surveyed areas, explore the causes of hypothermia, base on which it is expected to enable to project perioperative hypothermia incidence rate, to verify the effectiveness of perioperative hypothermia risk assessment questionnaire for patients under general anesthesia, and to provide guidance and evidence for the clinical practice of perioperative warming care.
Study design
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective surgery under general anesthesia.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| body temperatureintermittant tympanic temperature measurement during surgery | Other | – |
Primary outcome
The incidence rate of perioperative hypothermia in Turkey
Time frame: 2 months
4 secondary outcomes
The patient risk factors associated with perioperative hypothermia.
Time frame: 2 months
The surgery risk factors associated with perioperative hypothermia.
Time frame: 2 months
Complications related to perioperative hypothermia
Time frame: 2 months
Patient temperature management development strategies
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Background: PubMed 16199165Smith 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.
- Background: PubMed 11506130Sessler DI. Complications and treatment of mild hypothermia. Anesthesiology. 2001 Aug;95(2):531-43. doi: 10.1097/00000542-200108000-00040. No abstract available.
- Results publication: PubMed 14661656Doufas 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.
- Results publication: PubMed 10488289Mahoney CB, Odom J. Maintaining intraoperative normothermia: a meta-analysis of outcomes with costs. AANA J. 1999 Apr;67(2):155-63.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hulya Bilgin, Prof principal investigator
Turkish Society of Anesthesiology and Reanimation
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Hypothermia, run by Turkish Society of Anesthesiology and Reanimation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of perioperative hypothermia in Turkey (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02736630, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.