The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under moderate sedation and local anesthetic.
The study was a multi-site, prospective and retrospective, treatment-only post-market study of the H-TTS. The study was performed in a commercial environment. Patients were already have a scheduled tympanostomy procedure with the H-TTS under moderate sedation and local anesthetic.
Study Type
OBSERVATIONAL
Enrollment
109
Insertion of a ventilation tube under sedation and local anesthetic
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Cloud Ear, Nose & Throat
Saint Cloud, Minnesota, United States
Percentage of Procedures Converted From Sedation to General Anesthesia
Percentage of procedures that require conversion from sedation to general anesthesia
Time frame: Intra-operative
Rate of Intra-operative Adverse Events
Rate of intra-operative adverse events that occur from the beginning to the end of the procedure
Time frame: Intra-operative
Rate of Adverse Events Through Discharge
Rate of adverse events that occur between the end of the procedure and discharge
Time frame: Through discharge, estimated to be approximately 90 minutes post-procedure
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