NCT02733783

Design of a Model to Study Functionality of the Trigeminal Nerve in Relation to Controlled Nasal Fractures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary aim of the study is to create a model; in order to examine the effects of neural trauma in patients that are healthy individuals, induced by controlled nasal fractures during rhinoplasty, and the regeneration process in the weeks/months that follow. This study includes monitoring of subjective nasal symptoms with a visual analogue scale (VAS) score, peak nasal inspiratory flow (PNIF) measurements, collection of nasal secretions and nasal provocation (response to capsaicin and cold dry air (CDA) exposure).

Detailed description

The investigators will set up a prospective mono-center study. The investigators will utilize objective and subjective parameters in order to assess trigeminal nerve function at the level of the nasal mucosa before and after septorhinoplasty (as a model of controlled nasal fractures). The subjective parameters involve a visual analogue scale (VAS) score for each individual nasal symptom (nasal obstruction, facial pain/pressure, headache, rhinorrhea, sneezing, pruritus, post nasal drip, and loss of smell). An objective assessment includes measurement of PNIF (Peak Nasal Inspiratory Flow), the presence of neuropeptides in nasal secretions, (by introducing merocels and removing them 5 minutes later), short cold dry air (CDA) provocation and capsaicin provocation with subsequent measurements of PNIF and VAS scores and neuropeptides.

Conditions

• Fracture of Nasal Bones, Sequela

Interventions

Type	Name	Description
DEVICE	Cold dry air machine	Cold Dry Air (CDA)- nasal provocation: Compressed dry air is delivered through a transparent anaesthesia mask placed over the nose and mouth of the patients. Subjects are instructed to breath through the nose only. Exposure to CDA lasts for 15 minutes. The flow, measured by a gas flow analyzer of Dräger was set at 12,5 l/min. The temperature of the air reaching the nose is at -10° C with a relative humidity of 10%-15%.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-04-01
• Completion: 2017-12-01
• First posted: 2016-04-12
• Last updated: 2016-04-12