Clinical trial NCT03991156: AVATAR Anesthesia Alternative in Pediatric Radiotherapy: A Multi-Center Study
Official title: AVATAR Anesthesia Alternative in Pediatric Radiotherapy: A Multi-Center Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anesthesia
Keywords: Radiotherapy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The age range of patients is 3-10 years old, and there is no discrimination on ethnic background in recruitment for this study.

Brief summary: To determine the success rate of the AVATAR audio-visual system. All patients enrolled in the study will be counted, and each patient who is able to undergo at least one fraction without anesthesia will count as a success while each patient who does not have at least one fraction without anesthesia will count as a failure. The success rate will be the proportion of patients who are successes.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients ages 3-10 receiving radiotherapy qualify for enrollment.
* The patient must speak English or Spanish.

Exclusion Criteria:

* If parent/guardian is unable to take part in helping to complete questionnaires
* Patients with malignancies of the eye for which radiation is planned
* Patients that do not speak English or Spanish

Primary outcomes:
measure: Success rate of AVATAR system
timeFrame: 24 months
Secondary outcomes:
measure: Measure Fractional Success using AVATAR system
timeFrame: 24 months
measure: Determine the difference in patient anxiety between successful AVATAR patients and not-successful patients.
timeFrame: 24 months
measure: Compare the rates of anesthesia with historical controls
timeFrame: 24 months
measure: Determine the rate at which patients convert from requiring anesthesia to not requiring anesthesia while using AVATAR
timeFrame: 24 months
measure: Difference in health quality of life between subjects with or without anesthesia
timeFrame: 24 months
measure: Assess predictability for AVATAR patient success
timeFrame: 24 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute/Brigham & Women Children Hospital
state: Massachusetts
city: Minnesota
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Rochester
country: United States
facility: University of Rochester School of Medicine
state: New York
city: Chapel Hill
country: United States
facility: University North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's/UC Health Proton Therapy Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Memphis
country: United States
facility: St. Jude Children Hospital
state: Tennessee
Study officials:
affiliation: Stanford University
name: Susan M Hiniker
role: PRINCIPAL_INVESTIGATOR
References: