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

Disturbance; Temperature Regulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081000
• Other study ID #: CIRB2015/2817
• Status: Completed
• Phase: N/A
• First received: June 14, 2016
• Last updated: August 27, 2017
• Start date: October 2015
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: June 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disturbance; Temperature Regulation
• Hypothermia

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore
Singapore	Khoo Teck Phuat Hospital	Singapore
Singapore	KK Women's and Children's Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative hypothermia defined as core temperature<36 degrees Celsius	Mode of monitoring: naso/oropharyngeal/rectal temperatures for intra-opt tympanic membrane /infra-red scanner for post-opt	Single 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.