Inadvertent Hypothermia or Hyperthermia in Pediatric Radiotherapy Practices Under Anesthesia
An Observational Cohort Study of Inadvertent Hypothermia or Hyperthermia in Pediatric Radiotherapy Practices Under Anesthesia
1 other identifier
observational
152
1 country
1
Brief Summary
In prospective, observational cohort study, changes in body temperature will be investigated before the procedure and during recovery in Radiotherapy patients aged 0-18 years who need sedation due to childhood malignancies. The aims of this study were to measure the incidence and magnitude of changes in body temperature in children undergoing sedation or general anesthesia for Radiotherapy, and to determine their effects on the recovery process.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2022
CompletedFirst Posted
Study publicly available on registry
July 28, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedOctober 13, 2022
July 1, 2022
1 month
July 25, 2022
October 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
body temperature change among 2 time period
non-contact body temperature measured on forehead
time from before radiotherapy to the end of radiotherapy
recovery time from anesthesia
Time from the end of the procedure until the Modified Steward score ≥ 8 in the patient recovery room
the time from end of radiotherapy to discharging
Study Arms (1)
Radiotherapy under anesthesia
Interventions
Body temperature change will be investigated before the procedure and during recovery in Radiotherapy patients who need anesthesia due to childhood malignancies.
Eligibility Criteria
patients undergoing radiotherapy under anesthesia
You may qualify if:
- patients undergoing radiotherapy under anesthesia
You may not qualify if:
- family refusal to participate,
- chronic nausea and vomiting complaints,
- active infection,
- apnea history,
- cardiac disease, kidney and liver failure,
- anomalies that may cause difficult airway,
- metabolic diseases,
- neurological or muscular diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara City Hospital
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Betül Güven Aytaç, MD
Ankara City Hospital Bilkent
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
July 25, 2022
First Posted
July 28, 2022
Study Start
August 1, 2022
Primary Completion
September 1, 2022
Study Completion
October 1, 2022
Last Updated
October 13, 2022
Record last verified: 2022-07