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Perioperative Hypothermia: A Multi-center Study of Incidence, Risk Factors and Preventive Measures.

Perioperative Hypothermia: A Multi-center Study of Incidence, Risk Factors and Preventive Measures.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03081000
Enrollment
4000
Registered
2017-03-15
Start date
2015-10-31
Completion date
2017-06-30
Last updated
2017-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disturbance; Temperature Regulation

Brief summary

Aims:- Primary: To identify the incidence of intra-operative and post-operative hypothermia Secondary: To identify factors contributing to peri-operative hypothermia. To identify current anaesthetic practice in peri-operative temperature monitoring, use of active/warming measures by anaesthetists in various hospitals. To increase awareness of the problem of IPH and guidelines available.

Detailed description

Inadvertent peri-operative hypothermia (IPH) affects patients across all ages, occurring up to 50% in the unwarmed surgical patient. It carries significant morbidity and mortality including increased risk of myocardial infarction, bleeding, and surgical site infection, increased shivering and patient discomfort, as well as increased length of hospital stay. Guidelines have been published by the UK National Institute for Clinical Excellence (NICE) as well as the American Society of Anaesthesiologists. However, the compliance to such guidelines have been poor, and no local guidelines have been developed as yet. A one month audit was conducted in KKH Department of Paediatric Anaesthesia in 2014 which collected data on the incidence of perioperative hypothermia in patients undergoing general anaesthesia for a variety of surgeries. This preliminary audit demonstrated a 33.7% incidence of hypothermia in PACU among 164 patients. The investigators wish to carry out a more comprehensive audit to find out the incidence of IPH in both adult and paediatric surgical patients, identify risk factors and assess the current practice to prevent IPH across various healthcare institutions. The study aims to find out the incidence of IPH, identify the risk factors involved and find out the current preventive measures in various local hospitals; if not already in place, bring awareness to this problem and improve patient outcomes. This is a cross-sectional observational study, aiming to recruit 4000 patients of all ages, across 5 institutions over the course of 6 months. Patients will receive the current standard of care, as per the anaesthetist in charge, with regards to temperature monitoring, and the use of passive/active warming strategies. The method of temperature monitoring, warming or heat conservation techniques would be recorded and the patient's temperature would be measured at the recovery area post-operatively by the recovery nurse. In addition, patient demographics, surgical time, anaesthetic time, surgical procedure and method of anaesthetic, total fluids given, will also be recorded on a prospectively-designed data collection form.

Interventions

None listed

Sponsors

KK Women's and Children's Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No

Inclusion criteria

* All cases within specified time frame under General anaesthesia (GA), Regional anaesthesia (RA), or combined General and Regional Anaesthesia (GA/RA) not involving the use of extra-corporeal circuits.

Exclusion criteria

* Cases done under Monitored Anaesthesia Care (MAC) or that have the use of extracorporeal circuits. Patients that require direct admission to the intensive care unit (ICU) are also excluded as they do not transit through the recovery area.

Design outcomes

Primary

MeasureTime frameDescription
Post-operative hypothermia defined as core temperature<36 degrees CelsiusSingle core temperature recorded within 15 minutes upon arrival in PACU by the recovery nurse. Measurements will be taken for all recruited patients during the study period at each site.Mode of monitoring: naso/oropharyngeal/rectal temperatures for intra-opt tympanic membrane /infra-red scanner for post-opt

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026