Inadvertent Hypothermia or Hyperthermia in Pediatric Radiotherapy Practices Under Anesthesia

October 9, 2022 updated by: Betül Güven, Ankara City Hospital Bilkent

An Observational Cohort Study of Inadvertent Hypothermia or Hyperthermia in Pediatric Radiotherapy Practices Under Anesthesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients undergoing radiotherapy under anesthesia

Description

Inclusion Criteria:

  • patients undergoing radiotherapy under anesthesia

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Radiotherapy under anesthesia
Procedure: radiotherapy under anesthesia
Body temperature change will be investigated before the procedure and during recovery in Radiotherapy patients who need anesthesia due to childhood malignancies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body temperature change among 2 time period
Time Frame: time from before radiotherapy to the end of radiotherapy
non-contact body temperature measured on forehead
time from before radiotherapy to the end of radiotherapy
recovery time from anesthesia
Time Frame: the time from end of radiotherapy to discharging
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Betül Güven Aytaç, MD, Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2022

Primary Completion (ACTUAL)

September 1, 2022

Study Completion (ACTUAL)

October 1, 2022

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

July 27, 2022

First Posted (ACTUAL)

July 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 9, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E1-22-2700

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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