Hypothermia Following AnesthesiaNCT07470801
Incidence and Risk Factors of Intraoperative Hypothermia in Adult Patients After Protocol Implementation
An observational study of Hypothermia Following Anesthesia, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
Inadvertent intraoperative hypothermia is one of the most common complications in patients undergoing anesthesia. This condition is strongly associated with several adverse clinical. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypothermia Following Anesthesia
- How many people
- 361 participants
- Where
- 1 siteThailand
- Study dates
- 27 Feb 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients undergoing non-cardiac surgery under anesthetic care at Siriraj Hospital, a tertiary's care hospital in Bangkok, Thailand.
Who may be able to join
- Adult patients undergoing non-cardiac surgery under anesthesia service Patients undergoing surgery after the implementation of the temperature management protocol (from July 2024 onwards)
Who cannot join
- Procedures performed under local anesthesia or monitored anesthetic care Anesthesia duration of less than 60 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence and Risk Factors of Intraoperative Hypothermia in Adult Patients at Siriraj Hospital: An Evaluation After Implementation Management Protocol
Inadvertent intraoperative hypothermia is one of the most common complications in patients undergoing anesthesia. This condition is strongly associated with several adverse clinical. 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 perioperative temperature management guideline in July 2024. 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.
Read the 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.
- Conditions
- Hypothermia Following Anesthesia
- Keywords
- Hypothermia, Intraoperative hypothermia
- Medical subject headings
- Hypothermia
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative hypothermia
Presence of hypothermia defined as core temperature less than 36 C
Measured: November to December 2025
Secondary outcomes (8)
The proportion of patients who received intraoperative temperature monitoring
Percentage of patients receiving intraoperative temperature monitoring
Measured: November to December 2025
Time to onset hypothermia, duration of hypothermia, lowest temperature
Measured: November to December 2025
Incidence of postoperative hypothermia
Percentage of patients having core temperature less than 36 C at the arrival of the recovery unit
Measured: November to December 2025
Recovery time
Time from finished operation to patient transfer recorded in minutes
Measured: November to December 2025
Blood loss
Amount of blood loss recorded in mL
Measured: November to December 2025
Length of post-anesthesia care unit stay
The amount of time the patient spent in the recovery unit was recorded in minutes.
Measured: November to December 2025
Length of hospital stay
The total admission days recorded in days
Measured: November to December 2025
Blood transfusion
Amount of blood transfusion given intraoperatively in mL
Measured: November to December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start27 Feb 2026
- Primary completionOct 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia Following AnesthesiaStudies 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
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingkwan Wongyingsinn, MD, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470801
- Sponsor's protocol ID
- 053/2569(IRB2)
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of Intraoperative Hypothermia in Adult Patients at Siriraj Hospital: An Evaluation After Implementation Management Protocol
- ClinicalTrials.gov ID
- NCT07470801
- Acronym / sponsor ID
- 053/2569(IRB2)
- Conditions
- Hypothermia Following Anesthesia
- Keywords
- Hypothermia, Intraoperative hypothermia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Mar 2026 (actual)
- 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.
Inadvertent intraoperative hypothermia is one of the most common complications in patients undergoing anesthesia. This condition is strongly associated with several adverse clinical. 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 perioperative temperature management guideline in July 2024. 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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing non-cardiac surgery under anesthetic care at Siriraj Hospital, a tertiary's care hospital in Bangkok, Thailand.
Key inclusion criteria (1 listed)
- Adult patients undergoing non-cardiac surgery under anesthesia service Patients undergoing surgery after the implementation of the temperature management protocol (from July 2024 onwards)
Key exclusion criteria (1 listed)
- Procedures performed under local anesthesia or monitored anesthetic care Anesthesia duration of less than 60 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of intraoperative hypothermia
Time frame: November to December 2025
Presence of hypothermia defined as core temperature less than 36 C
8 secondary outcomes
The proportion of patients who received intraoperative temperature monitoring
Time frame: November to December 2025
Time to onset hypothermia, duration of hypothermia, lowest temperature
Time frame: November to December 2025
Incidence of postoperative hypothermia
Time frame: November to December 2025
Recovery time
Time frame: November to December 2025
Blood loss
Time frame: November to December 2025
Length of post-anesthesia care unit stay
Time frame: November to December 2025
Length of hospital stay
Time frame: November to December 2025
Blood transfusion
Time frame: November to December 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia Following Anesthesia, run by Siriraj Hospital at 1 site in Thailand.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of intraoperative hypothermia (time frame: November to December 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2026.