- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07470801
Incidence and Risk Factors of Intraoperative Hypothermia in Adult Patients After Protocol Implementation
Incidence and Risk Factors of Intraoperative Hypothermia in Adult Patients at Siriraj Hospital: An Evaluation After Implementation Management Protocol
Study Overview
Status
Conditions
Detailed Description
Inadvertent intraoperative hypothermia, defined as a core body temperature below 36 C, is one of the most common complications in patients undergoing anesthesia. This condition is strongly associated with several adverse clinical outcomes, including increased risk for surgical site infections, delayed wound healing, prolonged recovery and hospitalization, coagulopathy, and increased requirements for blood transfusion. Many risk factors are associated with inadvertent intraoperative hypothermia including: high ASA physical status, age >65-year, general anesthesia combined with neuraxial anesthesia, longer anesthesia duration, emergency major surgery, intraoperative blood loss and intravenous fluid volume received.
Despite the existence of international recommendations from organizations like the American Society of Anesthesiologists (ASA) and the National Institute for Health and Care Excellence (NICE)-which recommend interventions including active warming, using warm irrigation fluid, and continuous temperature monitoring to minimize the risk of intraoperative hypothermia, hypothermia remains prevalent in many settings. At Siriraj Hospital, a previous study revealed a high incidence rate of 74.4%, with only 16.3% of patients receiving intraoperative temperature monitoring. In response to these findings, Siriraj Hospital implemented a standardized perioperative temperature management guideline (protocol) in July 2024. This protocol recommends pre-warming and active warming strategies to mitigate extrinsic risk factors, such as low operating room temperatures and the administration of cold intravenous fluids.
However, it remains to be evaluated whether the implementation of this protocol has led to a meaningful change in clinical practice. The primary concern is whether the adherence to temperature monitoring for surgeries exceeding one hour has improved from the historical rate of 16.3%, and subsequently, whether this has resulted in a decreased incidence of hypothermia. Furthermore, intrinsic patient factors-such as age, Body Mass Index (BMI), and surgical complexity-continue to be potential variables that the protocol alone may not fully address.
To date, the real-world impact of this specific protocol on reducing hypothermia has not been formally evaluated. Therefore, this study is essential to evaluate the effectiveness of the Siriraj temperature management protocol. The findings will not only determine the current intraoperative monitoring rate and the incidence of hypothermia but also identify significant intrinsic risk factors that persist despite standardized care. This information will be vital for further quality improvement and ensuring patient safety in the perioperative setting at Siriraj Hospital.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bangkok
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Bangkok, Bangkok, Thailand, 10700
- Siriraj Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients undergoing non-cardiac surgery under anesthesia service Patients undergoing surgery after the implementation of the temperature management protocol (from July 2024 onwards)
Exclusion Criteria:
- Procedures performed under local anesthesia or monitored anesthetic care Anesthesia duration of less than 60 minutes
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of intraoperative hypothermia
Time Frame: November to December 2025
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Presence of hypothermia defined as core temperature less than 36 C
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November to December 2025
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The proportion of patients who received intraoperative temperature monitoring
Time Frame: November to December 2025
|
Percentage of patients receiving intraoperative temperature monitoring
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November to December 2025
|
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Time to onset hypothermia, duration of hypothermia, lowest temperature
Time Frame: November to December 2025
|
November to December 2025
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|
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Incidence of postoperative hypothermia
Time Frame: November to December 2025
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Percentage of patients having core temperature less than 36 C at the arrival of the recovery unit
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November to December 2025
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Recovery time
Time Frame: November to December 2025
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Time from finished operation to patient transfer recorded in minutes
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November to December 2025
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Blood loss
Time Frame: November to December 2025
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Amount of blood loss recorded in mL
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November to December 2025
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Length of post-anesthesia care unit stay
Time Frame: November to December 2025
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The amount of time the patient spent in the recovery unit was recorded in minutes.
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November to December 2025
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Length of hospital stay
Time Frame: November to December 2025
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The total admission days recorded in days
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November to December 2025
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Blood transfusion
Time Frame: November to December 2025
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Amount of blood transfusion given intraoperatively in mL
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November to December 2025
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 053/2569(IRB2)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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