- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04307095
Incidence of Postoperative Hypothermia and Associated Factors in Adult Patients Undergoing Surgery in Siriraj Hospital
Study Overview
Status
Conditions
Detailed Description
Inadvertent postanesthetic hypothermia is unintentional drop in core body temperature <36C (96.8F) immediately following an operation, which is a common problem in post anesthesia care unit (PACU). It has been implicated in negative outcomes in surgical patients, including prolonged effects of intraoperative anesthetic medication, increased insulin resistance, postoperative morbidity, delayed surgical wound healing; and prolonged stay in the recovery room and hospital1-7.
In the operating room (OR), patients have to expose to a low ambient temperature with little or no clothing, evaporation from the surgical area, an irrigated fluid in surgical area; and an administration of intravenous fluids. Moreover, many anesthetic agents have an influence on the autonomic thermoregulatory mechanism which causes vasodilatation. All these factors promote patients' unintentional loss of heat and cause hypothermia.
Even of a lot of efforts to keep patients warm intraoperatively and minimize hypothermia including optimizing ambient OR temperature and using of various warming devices, the incidences of postoperative hypothermia in PACU are still high with the reported magnitude ranges from 50%- 90%7. In Siriraj hospital, a study in 2011 reported an incidence of postoperative hypothermia in PACU of 45.4% (95% CI 39.61%- 51.23%)8. After that, various interventions aimed to prevent perioperative hypothermia were implemented such as maintaining the ambient room temperature of an OR; warming intravenous fluids, blood products, and irrigants; heated, humidified anesthetic gases; and using warming blankets, forced-air warming, layering drapes and head wraps. This study is initiated to determine the incidence of postoperative hypothermia and associated factors of postoperative hypothermia in adult patients underwent surgery 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, Faculty of medicine Siriraj hospital, Mahidol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients >18 years undergoing surgery with anesthesia service
- Stay at Postanesthetic care unit of Syamindra building, fifth floor, Siriraj hospital
Exclusion Criteria:
- Procedure performed under local anesthesia
- Patients with missing data of temperature
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body temperature
Time Frame: 1 min
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Body temperature after admit in PACU
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1 min
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mingkwan Wongyingsinn, MD, Siriraj Hospital
Publications and helpful links
General Publications
- Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
- Wartzek T, Muhlsteff J, Imhoff M. Temperature measurement. Biomed Tech (Berl). 2011 Oct;56(5):241-57. doi: 10.1515/BMT.2011.108.
- Insler SR, Sessler DI. Perioperative thermoregulation and temperature monitoring. Anesthesiol Clin. 2006 Dec;24(4):823-37. doi: 10.1016/j.atc.2006.09.001.
- Mauermann WJ, Nemergut EC. The anesthesiologist's role in the prevention of surgical site infections. Anesthesiology. 2006 Aug;105(2):413-21; quiz 439-40. doi: 10.1097/00000542-200608000-00025. No abstract available.
- Panagiotis K, Maria P, Argiri P, Panagiotis S. Is postanesthesia care unit length of stay increased in hypothermic patients? AORN J. 2005 Feb;81(2):379-82, 385-92. doi: 10.1016/s0001-2092(06)60420-1.
- Kiekkas P, Poulopoulou M, Papahatzi A, Souleles P. Effects of hypothermia and shivering on standard PACU monitoring of patients. AANA J. 2005 Feb;73(1):47-53.
- Wongyingsinn M, Pookprayoon V. Incidence and associated factors of perioperative hypothermia in adult patients at a university-based, tertiary care hospital in Thailand. BMC Anesthesiol. 2023 Apr 25;23(1):137. doi: 10.1186/s12871-023-02084-2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB889
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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