Evaluation of the Reliability of AAR as an Independent Tool for Surgical Indication in Nasal Obstruction (RHINOVE)

Intermunicipal Hospital Center Toulon

Status: Enrolling

Conditions: Nasal Obstruction

Treatments: Procedure: preoperative rhinomanometry

Study type: Observational

Funder types: Other

Identifiers

NCT07379775

2025-CHITS-018

Details and patient eligibility

About

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%.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 18 years or older with nasal obstruction (NO).
2. Patients scheduled for surgery: septoplasty ± turbinoplasty ± rhinoplasty for nasal obstruction.
3. Patients who have undergone a preoperative rhinomanometry assessment.
4. Patients consented to participation

Exclusion criteria

1. Nasal polyps.
2. Chronic edematous-purulent rhinosinusitis (e.g., cystic fibrosis).
3. Crusting rhinosinusitis (e.g., sarcoidosis, granulomatosis with polyangiitis [Wegener's]).
4. Current or previously treated nasal or sinus tumors, or patients undergoing tumor work-up

Trial design

200 participants in 1 patient group

Patients with nasal obstruction

Description:

Patients scheduled for surgery who underwent preoperative rhinomanometry

Treatment:

Procedure: preoperative rhinomanometry