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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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.

Thailand1 site
  • Siriraj Hospital

    Bangkok, Bangkok, 10700

Other trials in Thailand

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.

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.

  1. Incidence of intraoperative hypothermia

    Presence of hypothermia defined as core temperature less than 36 C

    Measured: November to December 2025

Secondary outcomes (8)
  1. The proportion of patients who received intraoperative temperature monitoring

    Percentage of patients receiving intraoperative temperature monitoring

    Measured: November to December 2025

  2. Time to onset hypothermia, duration of hypothermia, lowest temperature

    Measured: November to December 2025

  3. 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

  4. Recovery time

    Time from finished operation to patient transfer recorded in minutes

    Measured: November to December 2025

  5. Blood loss

    Amount of blood loss recorded in mL

    Measured: November to December 2025

  6. 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

  7. Length of hospital stay

    The total admission days recorded in days

    Measured: November to December 2025

  8. 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.

  1. First posted13 Mar 2026
  2. Study start27 Feb 2026
  3. Primary completionOct 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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)
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

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.

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