Evaluation of the Reliability of Anterior Active Rhinomanometry as an Independent Tool for Surgical Indication in Nasal Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To evaluate the reliability of an abnormal (vs. normal) binary result of preoperative anterior active rhinomanometry as an independent tool for confirming the indication for endonasal surgery in patients presenting with nasal obstruction.
研究概览
简要总结
Nasal obstruction (NO) affects ~30% of the population and is a very common reason for consultation in otorhinolaryngology (ORL). In the majority of cases, the origin is inflammatory (allergic rhinitis and chronic rhinosinusitis) while in a minority of cases, the origin is structural, including septal deviation and inferior turbinate hypertrophy.
NO significantly impairs patients' quality of life (QoL) and olfactory performance and also represents a contributing factor and comorbidity in asthma and obstructive sleep apnea syndrome. Several questionnaires for assessing QoL are available and routinely used to evaluate the impact of NO on patients : VAS, NOSE score, SNOT-22, and RhinoQOL score.
Several objective functional methods for assessing NO have been described : acoustic rhinometry, nasal peak inspiratory flow, and active rhinomanometry. Rhinomanometry is a simple, non-invasive functional assessment method that allows for objective and quantitative analysis of nasal airway patency, thereby complementing the clinical and imaging evaluation of NO.
It has been recommended for the diagnosis of NO in cases of chronic rhinitis and chronic rhinosinusitis with nasal polyposis. Rhinomanometry comprises anterior active (AAR), posterior, and per-nasal rhinomanometry. AAR is the most commonly used method and is the only technique routinely available to clinicians. AAR provides precise information regarding the presence of nasal resistance responsible for NO. However, it should not be used as a standalone diagnostic tool due to its poor correlation with QoL questionnaires such as VAS and NOSE.
Whether used alone or in combination with nasal decongestants, AAR provides a high predictive value for the outcomes of septoplasty and laser-assisted turbinoplasty.
When surgery is indicated, its performance depends on:
- type of obstruction or anatomical abnormality identified on clinical examination and/or computed tomography and/or AAR;
- patient's symptoms and impairment of QoL NOSE and SNOT-22;
- failure of a well-conducted first-line medical nasal treatment. Thus, in cases of septal deviation, septoplasty is performed; in cases of inferior turbinate mucosal hypertrophy with failure of medical treatment, turbinoplasty is performed; and in cases of mixed lesions, septo-turbinoplasty is performed.
However, the concordance rate between the surgical technique indicated by clinical examination and computed tomography and the indications suggested by AAR is only 48.5%.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older with nasal obstruction (NO).
- •Patients scheduled for surgery: septoplasty ± turbinoplasty ± rhinoplasty for nasal obstruction.
- •Patients who have undergone a preoperative rhinomanometry assessment.
- •Patients consented to participation
排除标准
- •Nasal polyps.
- •Chronic edematous-purulent rhinosinusitis (e.g., cystic fibrosis).
- •Crusting rhinosinusitis (e.g., sarcoidosis, granulomatosis with polyangiitis [Wegener's]).
- •Current or previously treated nasal or sinus tumors, or patients undergoing tumor work-up
研究组 & 干预措施
Patients with nasal obstruction
Patients scheduled for surgery who underwent preoperative rhinomanometry
干预措施: preoperative rhinomanometry (Procedure)
结局指标
主要结局
To evaluate the reliability of an abnormal (vs. normal) binary result of preoperative anterior active rhinomanometry as an independent tool for confirming the indication for endonasal surgery in patients presenting with nasal obstruction.
时间窗: the day of surgery
The result was considered normal if: Uninasal resistance ≤ 6 cmH₂O/L/s (or 0.6 Pa/cm³/s); Binasal resistance ≤ 3 cmH₂O/L/s (or 0.3 Pa/cm³/s). The criteria is 1) Percentage of patients with an abnormal versus normal preoperative AAR result; and 2) calculation of the positive and negative predictive values (PPV and NPV) of AAR as an independent tool for confirming surgical indication.
次要结局
- To evaluate the correlation between the preoperative NOSE score and a preoperative AAR considered abnormal.(preoperative visit)
- To evaluate the correlation between the preoperative SNOT-22 score and a preoperative AAR considered abnormal.(preoperative visit)
- To assess the improvement in patients' quality of life at 3 months postoperatively using the NOSE score in patients with a preoperative AAR considered abnormal(3 months after surgery)
- To assess the improvement in patients' quality of life at 3 months postoperatively using the SNOT-22 score in patients with a preoperative AAR considered abnormal(3 months after surgery)
- To assess the improvement in AAR at 3 months postoperatively in patients with a preoperative AAR considered abnormal(3 months after surgery)
- To assess the improvement in the apnea-hypopnea index (AHI) at 3 months postoperatively in patients with identified obstructive sleep apnea and a preoperative AAR considered abnormal(3 months after surgery)
- To assess the improvement in continuous positive airway pressure (CPAP) adherence at 3 months postoperatively in patients with identified obstructive sleep apnea and a preoperative AAR considered abnormal.(3 months after surgery)