Centre Hospitalier de la Dracénie
Draguignan, Var, 83007, France
Location status: Recruiting
Location contact
Charly BESSADIER, MD
CONTACT
0494605869 ext. +33
Heritsilavo Eloi RAMILISON, MD
CONTACT
0494605869 ext. +33
NCT Number: NCT07379775
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%.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Draguignan, Var, 83007, France
Location status: Recruiting
Charly BESSADIER, MD
CONTACT
0494605869 ext. +33
Heritsilavo Eloi RAMILISON, MD
CONTACT
0494605869 ext. +33
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
Time frame: 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.
Time frame: preoperative visit
Correlation coefficient between the preoperative NOSE score and the preoperative AAR result (normal/abnormal).
Time frame: preoperative visit
Correlation coefficient between the preoperative SNOT-22 score and the preoperative AAR result (normal/abnormal)
Time frame: 3 months after surgery
Difference between pre- and 3-month postoperative NOSE scores in patients with an abnormal preoperative AAR result
Time frame: 3 months after surgery
Difference between pre- and 3-month postoperative SNOT-22 scores in patients with an abnormal preoperative AAR result
Time frame: 3 months after surgery
Percentage of AAR results significantly improved at 3 months postoperatively in patients with an abnormal preoperative AAR
Time frame: 3 months after surgery
Difference between pre- and 3-month postoperative apnea-hypopnea index (AHI) in patients with identified sleep apnea and an abnormal preoperative AAR result
Time frame: 3 months after surgery
Difference between pre- and 3-month postoperative adherence to continuous positive airway pressure (CPAP) in patients with identified sleep apnea and an abnormal preoperative AAR result.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Other
Evaluation of the Reliability of Anterior Active Rhinomanometry as an Independent Tool for Surgical Indication in Nasal Obstruction
Acronym: RHINOVE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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