Peri-operative Hypothermia in Children

NCT03770364 | Completed

• 1 other identifier: 2017/2298
• Study Type: observational
• Target: 4,500
• Locations: 1 country
• Sites: 1

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

Conditions

Hypothermia Following Anesthesia, Sequela; Pediatric ALL

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Incidence of short term adverse outcomes of IPH in the paediatric population

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

• Incidence of long term adverse outcomes of IPH in the paediatric population

  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

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

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Shu Ying Lee, FANZCA, Mmed

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2017
• First Posted: December 10, 2018
• Study Start: April 18, 2017
• Primary Completion: December 31, 2018
• Study Completion: March 31, 2020
• Last Updated: September 29, 2020

Record last verified: 2020-02

Locations

SG (1)