--- title: Incidence and Risk Factors of Intraoperative Hypothermia in Adult Patients After Protocol Implementation nct_id: NCT07470801 overall_status: ACTIVE_NOT_RECRUITING sponsor: Siriraj Hospital study_type: OBSERVATIONAL primary_condition: Hypothermia Following Anesthesia countries: Thailand canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07470801.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07470801" ct_last_update_post_date: 2026-03-13 last_seen_at: "2026-05-12T06:29:15.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Incidence and Risk Factors of Intraoperative Hypothermia in Adult Patients After Protocol Implementation **Official Title:** Incidence and Risk Factors of Intraoperative Hypothermia in Adult Patients at Siriraj Hospital: An Evaluation After Implementation Management Protocol **NCT ID:** [NCT07470801](https://clinicaltrials.gov/study/NCT07470801) ## Key Facts - **Status:** ACTIVE_NOT_RECRUITING - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 361 - **Lead Sponsor:** Siriraj Hospital - **Conditions:** Hypothermia Following Anesthesia - **Start Date:** 2026-02-27 - **Completion Date:** 2027-06 - **CT.gov Last Update:** 2026-03-13 ## 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. ## 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** Yes ``` 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 ``` ## Primary Outcomes - **Incidence of intraoperative hypothermia** _(time frame: November to December 2025)_ — Presence of hypothermia defined as core temperature less than 36 C ## 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)_ ## Locations (1) - Siriraj Hospital, Bangkok, Bangkok, Thailand ## Recent Field Changes (last 30 days) - `outcomes.primary` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.siriraj hospital|bangkok|bangkok|thailand` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT07470801.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT07470801* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*