Dataset Information

Evaluation of Safety and Efficacy for an Intranasal Airway Device in Nasal Surgery.

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

SUBMITTER: Tripathi PB

PROVIDER: S-EPMC6439732 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Publications

Evaluation of Safety and Efficacy for an Intranasal Airway Device in Nasal Surgery.

Tripathi Prem B PB Majd Pejman P Ngo Tuan T Gu Jefferey T JT Sharma Giriraj K GK Badger Christopher C Bhandarkar Naveen D ND Wong Brian J F BJF

JAMA facial plastic surgery 20190101 1

<h4>Importance</h4>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.<h4>Objective</h4>To evaluate the safety and efficacy of an intraoperatively placed IA device in rhinoplasty and nasal surgery.<h4>Design, setting, and participants</h4>In this retrospective record review, the ...[more]

PMID: 30193353

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Project description:ImportanceNasal valve collapse is a primary cause of nasal airway obstruction (NAO). Patients with NAO and nasal valve collapse experience a variety of symptoms that lower their quality of life, such as nasal congestion, headache, sleep disturbance, daytime sleepiness, and snoring.ObjectiveTo determine if active treatment of the nasal valve with a temperature-controlled radiofrequency (TCRF) device, previously demonstrated superior to a sham procedure at 3 months, was safe and associated with sustained improvements in symptoms of NAO through 12 months.Design, setting, and participantsIn a prospective, multicenter, single-blinded, randomized clinical trial, patients in 16 centers in the US with index procedures between August and December 2020 were assigned to TCRF device treatment of the nasal valve or a sham control procedure (no RF energy). Patients had a baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score of 55 or greater with nasal valve collapse as the primary or substantial contributor to NAO. After primary end point evaluation at 3 months, eligible patients in the sham control arm crossed over to active treatment. Data analysis was performed between April and May 2022.InterventionsPatients were treated bilaterally with the TCRF device at 4 or fewer nonoverlapping areas on the nasal mucosa at the junction of the upper and lower lateral cartilage on the lateral nasal wall.Main outcomes and measuresThe primary end point measure was responder rate, defined as 20% or greater reduction in NOSE Scale score or 1 or greater reduction in NOSE Scale clinical severity category.ResultsA total of 108 patients received active treatment (77 as index active treatment, 31 after crossover). The mean (SD) age of patients was 48.5 (12.3) years; 66 (61.1%) were women. The combined group of patients receiving active treatment had a mean baseline NOSE Scale score of 76.3 (95% CI, 73.6-79.1). At 12 months (n = 88), the responder rate was 89.8% (95% CI, 81.7%-94.5%). The NOSE Scale score improved from baseline (mean change, -44.9 [95% CI, -52.1 to -37.7]). No device/procedure-related serious adverse events were reported.Conclusions and relevanceIn this follow-up of a cohort from a randomized clinical trial, the minimally invasive TCRF device, previously demonstrated to be superior to a sham procedure, was safe and associated with improvement in symptoms of NAO through 12 months postprocedure.Trial registrationClinicalTrials.gov Identifier: NCT04549545.

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Dataset Information

Evaluation of Safety and Efficacy for an Intranasal Airway Device in Nasal Surgery.

Importance

Objective

Design, setting, and participants

Exposures

Results

Conclusions and relevance

Level of evidence

Publications

Evaluation of Safety and Efficacy for an Intranasal Airway Device in Nasal Surgery.

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