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ObjectivesTo understand healthcare professionals’ and patients’ views and experiences of septoplasty and medical management (ie, nasal steroid and saline sprays) for nasal obstruction.DesignNested qualitative study as part of the Nasal Airway Obstruction Study (NAIROS) trial. We used in-depth interviews to develop a coding framework based on thematic analysis.SettingNAIROS was a trial based in the UK from January 2018 to December 2020 that aimed to compare the effectiveness of septoplasty versus medical management.ParticipantsWe purposively sampled and interviewed 14 healthcare professionals (surgeons, research nurses) and 31 patients involved in the NAIROS trial across 14 UK hospital sites.ResultsIn usual practice, surgeons’ decisions regarding treatment for nasal obstruction are based on a complex assessment of patients’ symptoms, history and anatomy. Surgeons viewed septoplasty as a complex although routine operation, which is not guaranteed to improve symptoms of nasal obstruction. Some patients saw septoplasty, intuitively, as a ‘fix’ for a bent septum, whereas others were keen to avoid surgery if possible. Healthcare professionals welcomed the increased use of standard measurements if these were shown to provide a reliable guide to patient outcomes. However, they felt that it was important to retain an element of clinical judgement. Despite generally good outcomes from septoplasty, some patients still felt they had received little to no benefit from the operation. Patients also reported being underprepared for postsurgery recovery. Experiences were more varied with medical management, with some experiencing symptom improvement, but others discontinuing treatment due to difficulty or pain using the sprays, or perceived ineffectiveness. Remembering to use the sprays could be perceived as burdensome, although most patients were able to incorporate this into their daily routines.ConclusionsOur qualitative study demonstrated varied individual experiences among patients undergoing septoplasty and medical management. Surgeons welcomed more standard measurements to guide decision-making for septoplasty. For patients, better information about treatment mechanisms, treatment delivery and aftercare, and the development of decision support tools would enable shared decision-making and help to provide optimal patient experience of the treatments.Trial registration numberISRCTN16168569.

Septoplasty (surgical correction of the deviated nasal septum) is the most frequently performed ear, nose, and throat operation in adults, but no randomised controlled trials or non-randomised comparative studies on the effectiveness of septoplasty have been published. Consequently, health-care providers, health insurance companies, and policy makers are concerned about the effectiveness of the procedure. We aimed to assess the effectiveness of septoplasty for nasal obstruction in adults with a deviated septum. We did this open, multicentre, pragmatic, randomised controlled trial in 16 secondary and two tertiary referral hospitals in the Netherlands. Adults (aged ≥18 years) with nasal obstruction, a deviated septum, and an indication to have septoplasty done were randomly allocated (1:1) to receive either septoplasty with or without concurrent turbinate surgery or non-surgical management. Patients were stratified by sex, age (<35 years or ≥35 years), and deviation severity (mild, moderate, or severe). The primary outcome was health-related quality of life, measured with the validated Glasgow Health Status Inventory at 12 months. Analyses were done on an intention-to-treat basis. The trial is registered with the Netherlands Trial Register, number NTR3868. Between Sept 2, 2013, and Dec 12, 2016, we randomly assigned 203 participants to receive either septoplasty with or without concurrent turbinate surgery (n=102) or non-surgical management (n=101). 189 participants were analysed at 12 months. At 12 months, mean score on the Glasgow Health Status Inventory of patients assigned to septoplasty was 72·2 (SD 12·2) and for those assigned to non-surgical management was 63·9 (SD 14·5, mean difference 8·3 [95% CI 4·5–12·1], favouring septoplasty). Septal abscess occurred in one surgical patient and septal perforation in two surgical patients. No side-effects of nasal medication were reported. Septoplasty is more effective than non-surgical management for nasal obstruction in adults with a deviated septum. This effect was sustained up to 24 months of follow-up. The Netherlands Organisation for Health Research and Development (ZonMw).

Nasal obstruction is often impact on quality of life in allergic rhinitis (AR). The steam inhalation is one of widely used home remedies to soothe and open the nasal passages. Furthermore, steam inhalation may provide change in objective nasal airway assessment. To compare the effect of steam inhalation on nasal obstruction between patients with AR and normal individuals, as well as the change in the cross-sectional area of the nasal cavity and in nasal airway resistance (NAR) between 2 groups. A prospective comparative, parallel group study was conducted in AR and normal individuals. Steam with the temperature of 42-44°C was inhaled. Variables obtained before and after steam inhalation were compared. After steam inhalation, nasal symptom score, combined global symptoms, and Visual Analog scale (VAS) of combined global symptoms of AR patients showed statistically significant improvement. Whereas, normal individuals, there was statistically significant improvement only in sneezing and combined global symptoms. Meanwhile, the change of each measurement score, combined global symptoms, and VAS of the symptoms in those with AR were significantly higher than those of normal individuals. Total nasal airflow, NAR, volume, and mean minimal cross-sectional area of AR patients tended to better improve after steam inhalation. The steam inhalation significantly improved nasal obstruction in AR patients, but no statistical significant difference between both groups for any parameters. The different response between the 2 groups may be due to different nasal mucosa sensitivity to stimuli.

Background Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Most septoplasties aim to improve diurnal and nocturnal nasal obstruction. The evidence base for septoplasty clinical effectiveness is hitherto very limited. Aims To establish, and inform guidance for, the best management strategy for individuals with nasal obstruction associated with a deviated septum. Methods/design A multicentre, mixed-methods, open label, randomised controlled trial of septoplasty versus medical management for adults with a deviated septum and a reduced nasal airway. Eligible patients will have septal deflection visible at nasendoscopy and a nasal symptom score ≥ 30 on the NOSE questionnaire. Surgical treatment comprises septoplasty with or without reduction of the inferior nasal turbinate on the anatomically wider side of the nose. Medical management comprises a nasal saline spray followed by a fluorinated steroid spray daily for six months. The recruitment target is 378 patients, recruited from up to 17 sites across Scotland, England and Wales. Randomisation will be on a 1:1 basis, stratified by gender and severity (NOSE score). Participants will be followed up for 12 months post randomisation. The primary outcome measure is the total SNOT-22 score at 6 months. Clinical and economic outcomes will be modelled against baseline severity (NOSE scale) to inform clinical decision-making. The study includes a recruitment enhancement process, and an economic evaluation. Discussion The NAIROS trial will evaluate the clinical effectiveness and cost-effectiveness of septoplasty versus medical management for adults with a deviated septum and symptoms of nasal blockage. Identifying those individuals most likely to benefit from surgery should enable more efficient and effective clinical decision-making, and avoid unnecessary operations where there is low likelihood of patient benefit. Trial registration EudraCT: 2017–000893-12, ISRCTN: 16168569 . Registered on 24 March 2017.

Background Septoplasty, i.e., surgical correction of the deviated nasal septum, is the most common ear, nose and throat (ENT) operation in adults. Currently the main indication to perform septoplasty is nasal obstruction. However, the effectiveness of septoplasty for nasal obstruction in adults with a deviated nasal septum remains uncertain. Scientific evidence is scarce and inconclusive, and internationally accepted guidelines are lacking. Moreover, there is no consensus on whether or not septoplasty should be combined with concurrent turbinate surgery. The objective of the current ongoing trial is to study the effectiveness of septoplasty (with or without concurrent turbinate surgery) as compared to non-surgical management for nasal obstruction in adults with a deviated nasal septum, both in terms of subjective (health-related quality of life) as well as objective (nasal patency) outcome measures. Methods/Design The study is designed as a pragmatic, multicenter, parallel-group, randomized controlled trial. A total of 200 adults will be enrolled with nasal obstruction based on a deviated nasal septum and an indication for septoplasty according to current medical practice in the Netherlands. Participants will be randomized to either septoplasty (with or without concurrent turbinate surgery as originally indicated by the otorhinolaryngologist) or a non-surgical watchful waiting strategy. Follow-up visits will be scheduled at 0, 3, 6, 12, and 24 months. During each follow-up visit, health-related quality of life questionnaires will be administered and measurements of four-phase rhinomanometry and peak nasal inspiratory flow will be performed. Costs will be studied using a patient-based diary. Effects of septoplasty on health-related quality of life (primary outcome) and nasal patency will be calculated as mean differences with 95 % confidence intervals. Subgroup analyses according to gender, age, and severity of the septal deviation will be performed. All analyses will be performed on an intention-to-treat basis. Discussion With the results of this study we aim to contribute to the development of evidence-based guidelines regarding indications for septoplasty. Trial registration Nederlands Trial Register/Dutch Trial Registry ( www.trialregister.nl ), trial identifying number: NTR3868 . Registered on 21 February 2013.

Background For years, the benefits of septoplasty have been questioned. Due to the scarce and inconclusive literature, several National Health Service (NHS) Clinical Commissioning Groups in England decided to add septal surgery to their list of restricted procedures with low clinical value. Recently, evidence was obtained that septoplasty is actually more effective than non-surgical management for nasal obstruction in adults with a deviated septum. However, the relation between costs and effects of septoplasty remains unknown. Methods We conducted an economic evaluation alongside an open, multicenter, pragmatic randomized controlled trial in two tertiary and 16 secondary referral hospitals in the Netherlands. Adults with nasal obstruction and a deviated septum were randomized to (1) septoplasty with or without concurrent turbinate surgery or (2) non-surgical management consisting of (a combination of) medical treatment and watchful waiting. Analyses were performed on an intention-to-treat basis. Single imputation nested in the bootstrap percentile method (using 5000 bootstrap replications) was performed to assess the effect of missing data. After 12 and 24 months, we assessed the incremental costs per quality-adjusted life year (QALY) gained from a healthcare and a societal perspective. Results A total of 203 adults were randomly assigned to septoplasty ( N  = 102) or non-surgical management ( N  = 101). After 12 months, the mean cost difference between septoplasty and non-surgical management using a healthcare or societal perspective was €1181 (95%CI €1038 to €1323) or €2192 per patient (95%CI €1714 to €2670), respectively. The mean QALY difference was 0.03 per patient (95%CI − 0.01 to 0.07). Incremental costs per QALY gained from a healthcare or societal perspective were €41,763 or €77,525, respectively. After 24 months, the mean cost difference between the two groups using a healthcare or societal perspective decreased to €936 (95%CI €719 to €1153) or €1671 per patient (95%CI €952 to €2390), respectively. The mean QALY difference increased to 0.05 per patient (95%CI − 0.03 to 0.14). Incremental costs per QALY gained from a healthcare or societal perspective became €17,374 or €31,024, respectively. Analyses of imputed data did not alter our findings. Conclusions Depending on the selected perspective, cost-effectiveness threshold, and time horizon, septoplasty has the potential to be cost-effective. Despite considerable uncertainty, septoplasty seems to be cost-effective from a healthcare perspective, after 24 months against a threshold of €20,000 per QALY. From a societal perspective, septoplasty is not yet cost-effective after 24 months, but it comes closer to the cost-effectiveness threshold as time passes by. Trial registration Nederlands Trial Register , NTR3868 ( https://www.trialregister.nl/trial/3698 ). Prospectively registered on February 21, 2013.

A fexofenadine/pseudoephedrine combination tablet (F/P) is an optimal product for nasal obstruction. It contains fexofenadine hydrochloride, a histamine H1-receptor antagonist for sneezing and rhinorrhea and pseudoephedrine hydrochloride, an α-adrenergic agonist. The effect of an antihistamine-decongestant on nasal obstruction has been demonstrated in previous studies, but onset of action and efficacy data on nasal obstruction are limited. We estimated the efficacy of F/P on nasal obstruction in patients with house dust mite-induced allergic rhinitis (AR) versus fexofenadine (F) using objective methods. In this single-center, single-dose, prospective, randomized, parallel-group study, 24 adult patients with a history of at least 2 years of AR and nasal obstruction were randomized to receive F/P or F. The effect on nasal obstruction was evaluated using nasal airflow and visual analog scale (VAS) score measured at 30-minute intervals before and for 8 hours after dosing. The primary end point was onset of action, based on a comparison of absolute change from baseline in nasal airflow between F/P and F. The protocol was registered in a clinical trial registry as UMIN 000041845. The onset of action for F/P was 30 minutes based on nasal airflow and 60 minutes based on VAS. F/P maintained a significant beneficial effect after onset of effect, while F showed no significant change during the test period. We found F/P had a clear effect on nasal obstruction associated with perennial AR when compared with F. There was a time lag in nasal airflow improvement and nasal obstruction relief.

Background Previous studies have shown that routine heated humidifier (HH) do not provide any benefit during continuous positive airway pressure (CPAP) titration if there are no significant naso-pharyngeal symptoms. In clinical practice, nasal diseases and upper airway symptoms are very common. This study investigates the effects of HH during CPAP titration in subjects with or without naso-pharyngeal symptoms. Methods Fifty-two patients who received polysomnography with CPAP titration were randomly assigned to HH and non-HH groups. Their nasal cavity, pharynx, and naso-pharynx were evaluated before CPAP titration, and a questionnaire on subjective sensation, including naso-pharyngeal symptoms, willingness to further use CPAP, and sleep improvement, was used. Objective (e.g., leak, apnea–hypopnea index (AHI) reduction, and optimal CPAP pressure level) and subjective data were analyzed between the two groups. Results In subjective sensation, the HH group did not have any benefit in further willingness to use CPAP and in sleep improvement, but had improved naso-pharyngeal symptoms ( p  = 0.043). There were no significant differences in leak, AHI reduction, and optimal CPAP pressure, even in patients with significant naso-pharyngeal symptoms. Conclusion Routine use of HH is not necessary during CPAP titration regardless of naso-pharyngeal symptoms.

Nasal congestion is one of the most common complaints dealt with in otorhinolaryngology. Side effects of decongestants are frequently seen in patients with chronic nasal congestion. This leads to an increasing demand of alternative treatments such as acupuncture. Future studies on acupuncture should aim at objectifying effects by both physical measuring and double blinding. Therefore, we were interested in whether these effects can potentially be measured as increase in nasal airflow (NAF) in ventus (\"wind\") disease of traditional Chinese medicine (TCM). Twenty-four patients with a history of nasal congestion due to hypertrophic inferior turbinates or chronic sinusitis without polyposis were additionally diagnosed according to the Heidelberg model of TCM. They were asked to score the severity of their nasal congestion on a visual analog scale (VAS). The acupuncturist was blinded according to the Heidelberg blinding assay. NAF was measured by using active anterior rhinomanometry (ARM). Specific verum acupoints according to the Chinese medical diagnosis were tested against nonspecific control acupoints. VAS and NAF were scored and measured before and 15 and 30 minutes after acupuncture. Control acupuncture showed a significant improvement in VAS and a deterioration of NAF. Verum acupuncture showed highly significant improvements in VAS and NAF. In addition, verum acupuncture improved NAF and VAS significantly over time. Our control and verum acupoints fulfill the condition of a control and verum treatment, respectively. Measuring NAF by RRM and scoring VAS are possible and reflect acupuncture effects in vivo.

The goal of this study was to compare the effectiveness of three treatments aiming to reduce nasal airflow resistance (NR): an external nasal strip device (Respir+), an internal nasal mechanical dilator (Nozovent), and a topical decongestant (Pernazène). NR was estimated by active posterior rhinometry at both a 0.5 L/s flow (NRF) and a 1 cm H2O pressure (NRp), under four conditions: in the basal state, with Respir+, with Nozovent, and after treatment with Pernazène. The efficacy of each treatment was assessed by the percentage changes in NRF and NRP (%NRF and %NRP, respectively). The study was performed in 15 healthy subjects. The efficacy of the treatments was significantly different, depending on whether it was evaluated by NRF or by NRP (p<0.02), with %NRF and %NRP values, respectively, equal to the following: 88±20% and 91±14% with Respir+, 58±17% and 70±13% with Nozovent, and 55±29% and 69±22% with Pernazène. NRF remained unchanged with Respir+, whereas it significantly decreased with Nozovent and Pernazène (p<0.0001). No significant difference was observed between the effects of the two latter treatments. These results demonstrate that Nozovent, which involves no risk of side effects or drug interactions, is an effective treatment to improve nasal breathing. Nozovent might therefore be recommended as an alternative to topical decongestants, for certain subjects presenting with nasal obstruction.