Peri-operative Hypothermia in Children

Pediatric ALL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770364
• Other study ID #: 2017/2298
• Status: Completed
• Start date: April 18, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: February 2020
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4500
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia Following Anesthesia, Sequela
• Pediatric ALL

Locations

Country	Name	City	State
Singapore	KK Women's and Children's 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	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
Primary	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	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
Secondary	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
Secondary	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