An observational study in Auditory Brainstem Response, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-02.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
This will be a prospective, blinded, cross-over study to compare the effects of two anesthetic techniques on the interpretability of auditory brainstem response testing in children.
The proposed study will be a single-center, prospective, crossover-controlled study of the two anesthetic techniques (propofol and sevoflurane). The investigators plan to enroll 80 patients who receive general anesthesia at Cincinnati Children's Hospital Medical Center Department of Radiology for ABR testing. A sample size recalculation will be performed during the study to determine the exact number of subjects necessary for sufficient power. As per standard anesthesia practice for this test in radiology department, all subjects will serve as their own control, receiving both anesthetic techniques within the same ABR testing session. The audiologist will employ broadband click stimulus testing after induction with Sevoflurane, after which the patient will be switched over to a propofol infusion and the sevoflurane stopped. After the completion of the remainder of the ABR (tone-burst testing), the audiologist will repeat the broadband click testing (now while under propofol anesthesia), and the results will be recorded. At this point, results will be de-identified, with the exception of which ear was tested and the intensity level, and these results will be reviewed by a panel of 5 audiologists. These audiologists will be blinded to the anesthetic technique and patient information. They will provide a judgment at each intensity level, for each ear whether or not a response is present (in a Yes/No format). A study coordinator blinded to the anesthetic technique will record the outcome data. The anesthesia providers and nursing team will not be blinded.
Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients will be recruited from the radiology ABR schedule
Exclusion Criteria:
Qualitative interpretability of ABR testing in the same patient undergoing two anesthetic techniques
This will be measured by a blinded panel of audiologist review the two ABR click test results and provide judgment at each intensity level, for each ear and whether or not a response is present.
Time frame: Participants will be followed for the duration of the ABR test approximately 60 - 90 minutes
Amplitude of Wave V of the ABR after broadband click stimulus
Time frame: Participants will be followed for the duration of the ABR test approximately 60 - 90 minutes
Latency of Wave V of the ABR after broadband click stimulus
Time frame: Participants will be followed for the duration of the ABR test approximately 60 - 90 minutes
Plan to share: No
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati