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

NCT07379775 | Recruiting

• 1 other identifier: 2025-CHITS-018
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Nasal Obstruction

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  the day of surgery

Secondary Outcomes (7)

• 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

Study Arms (1)

Patients with nasal obstruction

Patients scheduled for surgery who underwent preoperative rhinomanometry

Procedure: preoperative rhinomanometry

Interventions

preoperative rhinomanometry PROCEDURE

The performance of AAR requires a pressure sensor placed within a facial mask to measure the pressure at the entrance of the ventilated nasal cavity. Another sensor is placed in the nasal vestibule of the contralateral nasal cavity to extrapolate the pressure at the exit of the ventilated nasal cavity. Measurements are therefore performed alternately on the right and left sides, but never on both sides simultaneously. AAR can be performed at rest in the seated position after 20 min in the supine position, or during forced inspiration. In our practice, AAR is performed without the use of nasal decongestants. Normal values of nasal resistance measured by rhinomanometry are as follows: * Uninasal resistance ≤ 6 cmH₂O/L/s (or 0.6 Pa/cm³/s); * Binasal resistance ≤ 3 cmH₂O/L/s (or 0.3 Pa/cm³/s); * Uninasal resistance ≥ 0.6 Pa/cm³/s, with or without vasoconstrictor, suggests septal deviation; * Binasal resistance after VC ≥ 0.3 Pa/cm³/s suggests bilateral inferior turbinate hypertrophy

Patients with nasal obstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with nasal obstruction, scheduled for surgery, and having undergone preoperative rhinomanometry

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

Centre Hospitalier de la Dracénie

Draguignan, Var, 83007, France

RECRUITING

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Study Officials

• Heritsilavo Eloi RAMILISON, MD

  Centre Hospitalier de la Dracénie - Draguignan

  STUDY DIRECTOR

Central Study Contacts

Sophie Lafond

CONTACT

0483772062; sophie.lafond@ch-toulon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 30, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)