Back to resultsDesign of a Model to Study Functionality of the Trigeminal Nerve in Relation to Controlled Nasal Fractures
Primary Purpose
Fracture of Nasal Bones, Sequela
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cold dry air machine
Sponsored by
About this trial
This is an interventional basic science trial for Fracture of Nasal Bones, Sequela
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing septorhinoplasty, with planned bilateral osteotomies
- No rhinological symptoms/complaints (rhinorrhea, sneezing, itchiness, nasal obstruction)
- Age > 18 and < 65 years
- Written informed consent
- Willingness to adhere to visit schedules
- Adequate contraceptive precautions in female patients with childbearing potential
Exclusion Criteria:
- Age < 18 and > 65 years
Patients with nasal symptoms at baseline, defined as having more than 2,5 on VAS score
for individual nasal symptoms related to mucosal pathology
Nasal endoscopic signs of inflammatory pathology (rhinitis, rhinosinusitis with/without
nasal polyps)
Use of systemic steroid treatment, intranasal steroid treatment, oral leukotriene antagonists
or long acting antihistamines?
- Asthma
- Pregnancy or breastfeeding
Any disorder of which might compromise the ability of a patient to give truly informed
consent for participation in this study.
Enrollment in other investigational drug trial(s) or is receiving other investigational
agent(s) for any other medical condition.
- Contra-indications for local anaesthesia (Cocaine 5%)
- Smoking
- Systemic disease with lesions in ENT domain
- Malignancies or severe comorbidity
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
septorhinoplasty patients
Arm Description
Elective septorhinoplasty patients that will undergo bilateral osteotomies. All the patients will undergo cold dry air provocation and 3 hours later capsaicin provocation, during a preoperative visit, one week before the intervention and during three post-operative visits two weeks, three months and six months.
Outcomes
Primary Outcome Measures
changes from baseline PNIF (peak nasal inspiratory flow) at 2 weeks, 3 and 6 months after rhinoplasty
Short Cold Dry Air (CDA) provocation with symptom evaluation using VAS and PNIF post-provocation and collection of nasal fluid by Merocel after provocation.
changes from baseline VAS (visual analogue score) for nasal obstruction at 2 weeks, 3 and 6 months after rhinoplasty
The presence of nasal obstruction will be evaluated on a VAS scoring system (0-10 cm) on the baseline visit and on follow-up visits. All patients will be asked to mark their nasal obstruction on this VAS score on all visits before and after CDA and capsaicin provocation.
changes from baseline level of neuro mediators in nasal secretions, at 2 weeks, 3 and 6 months after rhinoplasty
Collection of nasal fluid: nasal fluid will be collected, by placing a small Merocel (4 cm) between the middle and inferior turbinate, for 5 minutes. This technique is a traumatic and painless for the patient, and allows a rapid collection of nasal fluid without the need for local anesthesia. The fluid will be stored at -20°C until analysis, i.e. measurement of mediators such as histamine, Substance P (SP), Neurokinin A and B (NKA, NKB), Nerve Growth Factor (NGF), eotaxin, NPY, CGRP by ELISA. All these measurements will be aggregated to arrive at one reported value an increase of neuro mediators in the immediate postoperative period and gradual decrease to the baseline levels over a period of time.
changes from baseline VAS (visual analogue score) for rhinorrhea at 2 weeks, 3 and 6 months after rhinoplasty
The presence of rhinorrhea will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their nasal rhinorrhea on this VAS score on all visits before and after CDA and capsaicin provocation.
changes from baseline VAS (visual analogue score) for facial pain at 2 weeks, 3 and 6 months after rhinoplasty
The presence of facial pain will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their facial pain on this VAS score on all visits before and after CDA and capsaicin provocation.
changes from baseline VAS (visual analogue score) for sneezing at 2 weeks, 3 and 6 months after rhinoplasty
The presence of sneezing will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their sneezing on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of facial pain will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their facial pain on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of sneezing will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their sneezing on this VAS score on all visits before and after CDA and capsaicin provocation.
changes from baseline VAS (visual analogue score) for pruritus at 2 weeks, 3 and 6 months after rhinoplasty
The presence of pruritus will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their pruritus on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of pruritus will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their pruritus on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of sneezing will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their sneezing on this VAS score on all visits before and after CDA and capsaicin provocation.
changes from baseline VAS (visual analogue score) for catarrh at 2 weeks, 3 and 6 months after rhinoplasty
The presence of catarrh will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their catarrh on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of pruritus will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their pruritus on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of catarrh will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their catarrh on this VAS score on all visits before and after CDA and capsaicin provocation.
changes from baseline VAS (visual analogue score) for sense of smell at 2 weeks, 3 and 6 months after rhinoplasty
The presence of facial pain will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their facial pain on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of pruritus will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their pruritus on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of hyposmia will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their sense of smell on this VAS score on all visits before and after CDA and capsaicin provocation.
changes from baseline VAS (visual analogue score) for headache at 2 weeks, 3 and 6 months after rhinoplasty
The presence of facial pain will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their facial pain on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of pruritus will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their pruritus on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of headache will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their headache on this VAS score on all visits before and after CDA and capsaicin provocation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02733783
Brief Title
Design of a Model to Study Functionality of the Trigeminal Nerve in Relation to Controlled Nasal Fractures
Official Title
Design of a Model to Study Functionality of the Trigeminal Nerve in Relation to Controlled Nasal Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Nasal Bones, Sequela
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
septorhinoplasty patients
Arm Type
Experimental
Arm Description
Elective septorhinoplasty patients that will undergo bilateral osteotomies. All the patients will undergo cold dry air provocation and 3 hours later capsaicin provocation, during a preoperative visit, one week before the intervention and during three post-operative visits two weeks, three months and six months.
Intervention Type
Device
Intervention Name(s)
Cold dry air machine
Intervention Description
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%.
Primary Outcome Measure Information:
Title
changes from baseline PNIF (peak nasal inspiratory flow) at 2 weeks, 3 and 6 months after rhinoplasty
Description
Short Cold Dry Air (CDA) provocation with symptom evaluation using VAS and PNIF post-provocation and collection of nasal fluid by Merocel after provocation.
Time Frame
Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
Title
changes from baseline VAS (visual analogue score) for nasal obstruction at 2 weeks, 3 and 6 months after rhinoplasty
Description
The presence of nasal obstruction will be evaluated on a VAS scoring system (0-10 cm) on the baseline visit and on follow-up visits. All patients will be asked to mark their nasal obstruction on this VAS score on all visits before and after CDA and capsaicin provocation.
Time Frame
Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
Title
changes from baseline level of neuro mediators in nasal secretions, at 2 weeks, 3 and 6 months after rhinoplasty
Description
Collection of nasal fluid: nasal fluid will be collected, by placing a small Merocel (4 cm) between the middle and inferior turbinate, for 5 minutes. This technique is a traumatic and painless for the patient, and allows a rapid collection of nasal fluid without the need for local anesthesia. The fluid will be stored at -20°C until analysis, i.e. measurement of mediators such as histamine, Substance P (SP), Neurokinin A and B (NKA, NKB), Nerve Growth Factor (NGF), eotaxin, NPY, CGRP by ELISA. All these measurements will be aggregated to arrive at one reported value an increase of neuro mediators in the immediate postoperative period and gradual decrease to the baseline levels over a period of time.
Time Frame
Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
Title
changes from baseline VAS (visual analogue score) for rhinorrhea at 2 weeks, 3 and 6 months after rhinoplasty
Description
The presence of rhinorrhea will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their nasal rhinorrhea on this VAS score on all visits before and after CDA and capsaicin provocation.
Time Frame
Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
Title
changes from baseline VAS (visual analogue score) for facial pain at 2 weeks, 3 and 6 months after rhinoplasty
Description
The presence of facial pain will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their facial pain on this VAS score on all visits before and after CDA and capsaicin provocation.
Time Frame
Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
Title
changes from baseline VAS (visual analogue score) for sneezing at 2 weeks, 3 and 6 months after rhinoplasty
Description
The presence of sneezing will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their sneezing on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of facial pain will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their facial pain on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of sneezing will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their sneezing on this VAS score on all visits before and after CDA and capsaicin provocation.
Time Frame
Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
Title
changes from baseline VAS (visual analogue score) for pruritus at 2 weeks, 3 and 6 months after rhinoplasty
Description
The presence of pruritus will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their pruritus on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of pruritus will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their pruritus on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of sneezing will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their sneezing on this VAS score on all visits before and after CDA and capsaicin provocation.
Time Frame
Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
Title
changes from baseline VAS (visual analogue score) for catarrh at 2 weeks, 3 and 6 months after rhinoplasty
Description
The presence of catarrh will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their catarrh on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of pruritus will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their pruritus on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of catarrh will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their catarrh on this VAS score on all visits before and after CDA and capsaicin provocation.
Time Frame
Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
Title
changes from baseline VAS (visual analogue score) for sense of smell at 2 weeks, 3 and 6 months after rhinoplasty
Description
The presence of facial pain will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their facial pain on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of pruritus will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their pruritus on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of hyposmia will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their sense of smell on this VAS score on all visits before and after CDA and capsaicin provocation.
Time Frame
Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
Title
changes from baseline VAS (visual analogue score) for headache at 2 weeks, 3 and 6 months after rhinoplasty
Description
The presence of facial pain will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their facial pain on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of pruritus will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their pruritus on this VAS score on all visits before and after CDA and capsaicin provocation.
The presence of headache will be evaluated on a VAS scoring system (0-10 cm) on the baseline and follow-up visits. All patients will be asked to mark their headache on this VAS score on all visits before and after CDA and capsaicin provocation.
Time Frame
Before and after each test (cold dry air provocation) during the pre-operative visit (one week before the intervention) and the three postoperative visits (two weeks, three months and six months after the intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients undergoing septorhinoplasty, with planned bilateral osteotomies
No rhinological symptoms/complaints (rhinorrhea, sneezing, itchiness, nasal obstruction)
Age > 18 and < 65 years
Written informed consent
Willingness to adhere to visit schedules
Adequate contraceptive precautions in female patients with childbearing potential
Exclusion Criteria:
Age < 18 and > 65 years
Patients with nasal symptoms at baseline, defined as having more than 2,5 on VAS score
for individual nasal symptoms related to mucosal pathology
Nasal endoscopic signs of inflammatory pathology (rhinitis, rhinosinusitis with/without
nasal polyps)
Use of systemic steroid treatment, intranasal steroid treatment, oral leukotriene antagonists
or long acting antihistamines?
Asthma
Pregnancy or breastfeeding
Any disorder of which might compromise the ability of a patient to give truly informed
consent for participation in this study.
Enrollment in other investigational drug trial(s) or is receiving other investigational
agent(s) for any other medical condition.
Contra-indications for local anaesthesia (Cocaine 5%)
Smoking
Systemic disease with lesions in ENT domain
Malignancies or severe comorbidity
12. IPD Sharing Statement
Learn more about this trial
Design of a Model to Study Functionality of the Trigeminal Nerve in Relation to Controlled Nasal Fractures
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