Peri-operative Hypothermia in Children

Peri-operative Hypothermia in Children: Improving Outcomes With Risk Prediction

This study aims to determine the incidence of hypothermia in the local paediatric population in the peri-operative period, identify the risk factors involved, and thereafter develop and implement clinical practice guidelines to reduce IPH such that temperature monitoring and heat conservation measures can be implemented in a cost-effective way. The secondary objectives are to determine the adverse outcomes of hypothermia and warming measures

Study Overview

• Status: Completed
• Conditions: Pediatric ALL; Hypothermia Following Anesthesia, Sequela

Detailed Description

Background Hypothermia, defined as core body temperature less than 36 degrees Celsius, occurs frequently during the course of surgery in patients across all ages, especially in the young. It causes significant medical consequences including cardiac events, bleeding, surgical site infection, increased shivering and patient discomfort, as well as longer hospital stays. Although guidelines exist for health care providers in terms of temperature management during surgery, these guidelines are not always followed as the warming measures can be costly, for example, single-use temperature probes and disposable blankets, with potential risks of the equipment overheating causing burns and contamination during surgery

Methodology The investigators aim to include up to 6,000 children presenting for either scheduled or emergency surgeries. Core temperature before, during and after surgery using routine temperature monitoring devices such as tympanic, axillary, oral, rectal and SPOTON (a non-invasive method using a sticker placed on the forehead) will be measured. Other outcomes collected will include cardiac arrhythmias, blood loss, hyperthermia, burn injuries, shivering, discomfort, length of PACU and length of hospitalization, wound infection rates, . Patients will receive the usual heat-loss prevention and warming measures.

Interim analysis of the first 2000 patients using the SPOTON method of continuous core temperature monitoring will be done to determine incidence and duration of peri-operative hypothermia. This monitoring modality will be compared for agreement with the conventional tympanic and forehead infra-red thermoscan methods. Patient and perioperative risk factors predisposing to hypothermia will be identified to guide in the formulation of clinical practice guidelines tailored to the local population. Guidelines will be implemented, and post-implementation incidence of IPH will be determined A pre- versus post-implementation cost analysis will be carried out.

• Study Type: Observational
• Enrollment (Actual): 4500

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Recruitment of participants: consecutive sampling of eligible participants recruited from daily operating lists in major and day surgery operating theatres

Description

Inclusion Criteria:

• All paediatric patients ages 16 and younger undergoing elective or emergency surgeries in paediatric major and day surgical operating theaters in KK women's and Children's Hospital.

Exclusion Criteria:

• Patients undergoing operative procedures under local anaesthesia
• Patients with impaired temperature control e.g., severe head injury, febrile illness
• Patients who are admitted to intensive care unit (ICU) post-operatively.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence (%) of perioperative hypothermia	Hypothermia is defined as Core temperature<36 degrees Celsius. Incidence of hypothermia is the occurence of hypothermia, measured in percentage(%).	From induction of anaesthesia to discharge from PACU, approximately 8 hours
Duration (minutes) of perioperative hypothermia	Hypothermia is defined as Core temperature<36 degrees Celsius. Duration of hypothermia is defined as the duration of time in minutes where temperature is less than 36 degrees celsius.	From induction of anaesthesia to discharge from PACU, approximately 8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of short term adverse outcomes of IPH in the paediatric population	Short term adverse outcomes include intra-operative blood loss, arrhythmia, post-anaesthesia shivering, discomfort from cold, PACU stay	From induction of anaesthesia to discharge from PACU, approximately 8 hours
Incidence of long term adverse outcomes of IPH in the paediatric population	Long term outcomes include: surgical site infection and hospitalization stay	From PACU discharge time up to 6 months post-surgery
Incidence of adverse outcomes of warming interventions in the paediatric population eg. Hyperthermia and burns injury	Hyperthermia cTemp >38 ºC, burns injury	From induction of anaesthesia to discharge from PACU, approximately 8 hours

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Investigators: Principal Investigator: Shu Ying Lee, FANZCA, Mmed, KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: August 27, 2017
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: 2017/2298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No