Brilliant X-rays using a Two-Stage Plasma Insertion Device.
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ABSTRACT:
SUBMITTER: Holloway JA
PROVIDER: S-EPMC5479796 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesInsertion of tympanostomy tubes (TT) is generally accomplished in children in the operating room under general anesthesia. We report on 229 children treated in-office with a novel device.MethodsInvestigators participated in an IRB-approved, prospective, single arm, multisite investigation of in-office TT placement in awake children. Topical anesthetic was applied, and protective restraint was used. TT placement was performed with a single-pass TT insertion device. Safety was assessed by monitoring procedural events.ResultsFour hundred and forty-four ears were treated in 229 children at 10 sites. Children were in age groups 6-24 months (n = 211, mean = 13 months) and 5-12 years (n = 18, mean = 8.3 years). Two hundred and fifteen children received bilateral TT placement, and 14 received unilateral placement. Overall, 226/229 (98.7%) children had successful TT placement in the office (209/211 in 6-24 months and 17/18 in 5-12 years). Three children were rescheduled for the operating room due to anatomical challenges or patient movement. Median procedure time for bilateral cases in both age groups was 4:53. Two minor adverse events (AEs) were reported in one patient. Per independent assessment of 30 procedure videos by clinicians, TT placement was tolerated acceptably by all children.ConclusionIn-office TT placement in awake young children using topical anesthetic, enabled by a single pass delivery device, was safe, successful and well tolerated. The American Academy of Otolaryngology (AAO) recently released a Position Statement supporting in-office TT placement in appropriate children. These results affirm an in-office alternative for clinicians and parents who have concerns with the risk, inconvenience and cost of surgery in an operating room under general anesthesia.Level of Evidence: 2c.Clinical Trials Registration Number: NCT03544138.
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Project description:OBJECTIVE::To evaluate the exposure parameters, radiation protection, absorbed dose and radiographic image quality of the DIOX® intraoral portable radiography device. METHODS::The exposure parameters were measured using the Xi UNFORS detector. Operator exposure to secondary radiation was measured using the 1800cc ionization chamber coupled to the electrometer. The absorbed dose (D) in the patient was calculated using TLD-100H positioned in the Alderson RANDO anthropomorphic simulator. The quality of the radiographic digital image was assessed by comparing radiographic images obtained from two conventional devices (CS 2200®, Carestream Health; Heliodent plus®, Sirona Dental Systems GMbH) with the radiological simulator of the upper molar region RMI (Radiation Measurements Instruments), using three acquisition sensors: Kodak RVG 5000® and Kodak PSP®, Eastman Kodak Company, Rochester, NY; EVO Micro Image®, Brazil. RESULTS::The DIOX intraoral portable radiographic device demonstrated reliability in relation to the performance of the standard evaluated parameters, except for the diameter of the radiation field (5.8 ?mm) less or greater. No evidence of device head radiation was detected. The Pb lead protection of the apparatus attenuates the secondary radiation, thus protecting the operator. However, it was observed that the region of the operator's gonads was the most exposed during the measurements. In the Alderson RANDO anthropomorphic simulator, the highest value of D was in the region corresponding to the submandibular and lingual glands of the left side (0.568 mGy). The image quality of the DIOX portable radiographic apparatus presented quality standards equivalent to those produced by the two conventional radiographic devices. CONCLUSION::The DIOX intraoral portable radiography device demonstrated reliability in relation to the quality control and radioprotection criteria, according to international standards. Results obtained demonstrated the safe use of the DIOX intraoral portable radiography device and indicated the need for debate and change in international sanitary oversight standards regarding the use of portable XR devices in dentistry.
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