NCT07470801

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Feb 2026Jun 2027

Study Start

First participant enrolled

February 27, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

March 6, 2026

Last Update Submit

March 10, 2026

Conditions

Keywords

HypothermiaIntraoperative hypothermia

Outcome Measures

Primary Outcomes (1)

  • Incidence of intraoperative hypothermia

    Presence of hypothermia defined as core temperature less than 36 C

    November to December 2025

Secondary Outcomes (8)

  • The proportion of patients who received intraoperative temperature monitoring

    November to December 2025

  • Time to onset hypothermia, duration of hypothermia, lowest temperature

    November to December 2025

  • Incidence of postoperative hypothermia

    November to December 2025

  • Recovery time

    November to December 2025

  • Blood loss

    November to December 2025

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing non-cardiac surgery under anesthetic care at Siriraj Hospital, a tertiary's care hospital in Bangkok, Thailand.

You may qualify if:

  • Adult patients undergoing non-cardiac surgery under anesthesia service Patients undergoing surgery after the implementation of the temperature management protocol (from July 2024 onwards)

You may not qualify if:

  • Procedures performed under local anesthesia or monitored anesthetic care Anesthesia duration of less than 60 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 13, 2026

Study Start

February 27, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations