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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04307095
Other study ID # IRB889
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 16, 2020
Est. completion date January 15, 2022

Study information

Verified date May 2022
Source Siriraj Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Inadvertent postanesthetic hypothermia is unintentional drop in core body temperature <36C (96.8F) immediately following an operation, caused by multiple factors, and had lead to negative outcomes. In our institute, a study in 2011 reported an incidence of postoperative hypothermia in PACU of 45.4% (95% CI 39.61%- 51.23%). After that, various interventions aimed to prevent perioperative hypothermia were implemented. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 742
Est. completion date January 15, 2022
Est. primary completion date November 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand Siriraj Hospital, Faculty of medicine Siriraj hospital, Mahidol University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (6)

Insler SR, Sessler DI. Perioperative thermoregulation and temperature monitoring. Anesthesiol Clin. 2006 Dec;24(4):823-37. Review. — View Citation

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. — View Citation

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. Review. Erratum in: Anesthesiology. 2006 Oct;105(4):868. — View Citation

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. — View Citation

Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76. Review. — View Citation

Wartzek T, Mühlsteff J, Imhoff M. Temperature measurement. Biomed Tech (Berl). 2011 Oct;56(5):241-57. doi: 10.1515/BMT.2011.108. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Body temperature Body temperature after admit in PACU 1 min
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