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RECRUITING
NCT07379775

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

Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

View on ClinicalTrials.gov

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%.

Official title: Evaluation of the Reliability of Anterior Active Rhinomanometry as an Independent Tool for Surgical Indication in Nasal Obstruction

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2026-01-27

Completion Date

2028-03

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

PROCEDURE

preoperative rhinomanometry

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

Locations (1)

Centre Hospitalier de la Dracénie

Draguignan, Var, France