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Completed

NCT Number: NCT03770364

Peri-operative Hypothermia in Children

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence (%) of perioperative hypothermia

    Time frame: From induction of anaesthesia to discharge from PACU, approximately 8 hours

    Hypothermia is defined as Core temperature<36 degrees Celsius. Incidence of hypothermia is the occurence of hypothermia, measured in percentage(%).

  2. Duration (minutes) of perioperative hypothermia

    Time frame: From induction of anaesthesia to discharge from PACU, approximately 8 hours

    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.

Secondary outcomes

  1. Incidence of short term adverse outcomes of IPH in the paediatric population

    Time frame: From induction of anaesthesia to discharge from PACU, approximately 8 hours

    Short term adverse outcomes include intra-operative blood loss, arrhythmia, post-anaesthesia shivering, discomfort from cold, PACU stay

  2. Incidence of long term adverse outcomes of IPH in the paediatric population

    Time frame: From PACU discharge time up to 6 months post-surgery

    Long term outcomes include: surgical site infection and hospitalization stay

  3. Incidence of adverse outcomes of warming interventions in the paediatric population eg. Hyperthermia and burns injury

    Time frame: From induction of anaesthesia to discharge from PACU, approximately 8 hours

    Hyperthermia cTemp >38 ºC, burns injury

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Dec 10, 2018
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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