1. Evaluation of Safety and Efficacy for an Intranasal Airway Device in Nasal Surgery
- Author
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Christopher Badger, Brian J. F. Wong, Giriraj K. Sharma, Naveen D. Bhandarkar, Pejman Majd, Prem B. Tripathi, Jefferey T. Gu, and Tuan Ngo
- Subjects
Male ,medicine.medical_specialty ,medicine.medical_treatment ,MEDLINE ,Prosthesis Design ,Rhinoplasty ,chemistry.chemical_compound ,Postoperative Complications ,Silicone ,Surveys and Questionnaires ,Nose Diseases ,otorhinolaryngologic diseases ,medicine ,Humans ,Nasal surgery ,Retrospective Studies ,Original Investigation ,Equipment Safety ,business.industry ,Medical record ,Retrospective cohort study ,Prostheses and Implants ,respiratory system ,respiratory tract diseases ,Surgery ,chemistry ,Female ,Nasal administration ,Nasal Obstruction ,business ,Airway - Abstract
IMPORTANCE: Postoperative packing in nasal surgery often results in nasal obstruction and discomfort. Commercially available silicone intranasal airways (IAs) serve as dual-nasal airway tubes aimed at alleviating this process, but the safety and efficacy of these devices are unknown. OBJECTIVE: To evaluate the safety and efficacy of an intraoperatively placed IA device in rhinoplasty and nasal surgery. DESIGN, SETTING, AND PARTICIPANTS: In this retrospective record review, the medical records of patients undergoing nasal surgery with insertion of the IA at a single institution from 2012 to 2017 were reviewed. After review of over 200 patients, a questionnaire was developed to assess device efficacy. EXPOSURES: Use of the IA device. The IA is 12 cm long, anchored across the columella, extends distally along the nasal floor, and has a proximal external portion used for cleaning and maintaining patency. Placed intraoperatively, the device aims to support air flow postoperatively in the face of edema, hemorrhage, and packing. RESULTS: A total of 302 operations in 300 patients were analyzed, including primary and revision septorhinoplasty. A total of 24 (7.9%) patients self-removed or inadvertently dislodged the IA. Minor acute postoperative complications not unique to airway insertion included cellulitis in 4 (1.3%) participants and epistaxis in 6 (2%). Postoperatively, 1 (0.3%) patient developed dehiscence along transcolumellar incisions. A total of 59 patients (100% compliance) completed the efficacy questionnaire. The mean breathing score was between good and average (2.9 of 5), comfort scores between comfortable and average (2.9 of 5), and mean ease of irrigation score was between very easy and easy (1.96 of 5). The device was irrigated on average 3.57 times per day. A total of 43 (76%) particpiants had full patency or only partial obstruction, compared with 13 (24%) patients with total obstruction. In all patients, with or without obstruction, the effect lasted an average of 4 days. CONCLUSIONS AND RELEVANCE: The device is safe and well-tolerated for maintaining patency of the nasal airway in patients undergoing rhinoplasty and nasal reconstruction without increased risk of incisional dehiscence. LEVEL OF EVIDENCE: 4.
- Published
- 2019
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