Hypothermia; AnesthesiaNCT05478850
Inadvertent Hypothermia or Hyperthermia in Pediatric Radiotherapy Practices Under Anesthesia
An observational study of Hypothermia; Anesthesia and Hyperthermia, Anesthesia Related, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Hypothermia; Anesthesia, Hyperthermia, Anesthesia Related, Radiotherapy Side Effect
- What is being tested?
- radiotherapy under anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 152 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients undergoing radiotherapy under anesthesia
Who may be able to join
- patients undergoing radiotherapy under anesthesia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hypothermia; Anesthesia, Hyperthermia, Anesthesia Related, Radiotherapy Side Effect, Childhood Cancer
- Being tested
- radiotherapy under anesthesia
- Keywords
- Hypothermia; Anesthesia, Hyperthermia, Anesthesia Related, Radiotherapy Side Effect, Childhood Cancer
- Medical subject headings
- Hypothermia, Malignant Hyperthermia, Radiation Injuries, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapy under anesthesiaProcedure or surgery
Body temperature change will be investigated before the procedure and during recovery in Radiotherapy patients who need anesthesia due to childhood malignancies.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy under anesthesia | Not described Receives: Procedure: radiotherapy under anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
body temperature change among 2 time period
non-contact body temperature measured on forehead
Measured: 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
Measured: the time from end of radiotherapy to discharging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Aug 2022
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia; AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Güven, Ankara City Hospital Bilkent
- Investigators
- Betül Güven Aytaç, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478850
- Sponsor's protocol ID
- E1-22-2700
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study of Inadvertent Hypothermia or Hyperthermia in Pediatric Radiotherapy Practices Under Anesthesia
- ClinicalTrials.gov ID
- NCT05478850
- Acronym / sponsor ID
- E1-22-2700
- Conditions
- Hypothermia; Anesthesia, Hyperthermia, Anesthesia Related, Radiotherapy Side Effect, Childhood Cancer
- Keywords
- Hypothermia; Anesthesia, Hyperthermia, Anesthesia Related, Radiotherapy Side Effect, Childhood Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy under anesthesia | – | Procedure: radiotherapy under anesthesia |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients undergoing radiotherapy under anesthesia
Key inclusion criteria (1 listed)
- patients undergoing radiotherapy under anesthesia
Key exclusion criteria (8 listed)
- family refusal to participate,
- chronic nausea and vomiting complaints,
- active infection,
- apnea history,
- cardiac disease, kidney and liver failure,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiotherapy under anesthesiaBody temperature change will be investigated before the procedure and during recovery in Radiotherapy patients who need anesthesia due to childhood malignancies. | Procedure or surgery | Radiotherapy under anesthesia |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betül Güven Aytaç, MD principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia; Anesthesia and Hyperthermia, Anesthesia Related, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body temperature change among 2 time period (time frame: time from before radiotherapy to the end of radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.