Clinical trial NCT03770364: Peri-operative Hypothermia in Children
Official title: Peri-operative Hypothermia in Children: Improving Outcomes With Risk Prediction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia Following Anesthesia, Sequela
Pediatric ALL
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2018-12-10
Enrollment: 4500
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence (%) of perioperative hypothermia
timeFrame: From induction of anaesthesia to discharge from PACU, approximately 8 hours
measure: Duration (minutes) of perioperative hypothermia
timeFrame: From induction of anaesthesia to discharge from PACU, approximately 8 hours
Secondary outcomes:
measure: Incidence of short term adverse outcomes of IPH in the paediatric population
timeFrame: From induction of anaesthesia to discharge from PACU, approximately 8 hours
measure: Incidence of long term adverse outcomes of IPH in the paediatric population
timeFrame: From PACU discharge time up to 6 months post-surgery
measure: Incidence of adverse outcomes of warming interventions in the paediatric population eg. Hyperthermia and burns injury
timeFrame: From induction of anaesthesia to discharge from PACU, approximately 8 hours
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Shu Ying Lee, FANZCA, Mmed
role: PRINCIPAL_INVESTIGATOR
References: