Xylometazoline nasal spray realizes vasoconstricion in the nasal mucosa, which will be assessed and visualized using SDF imaging.
ID
Bron
Verkorte titel
Aandoening
20 healthy volunteers will be exposed to either provocation with xylometazoline nasal spray or placebo.
Ondersteuning
Department of Otolaryngology and Clinical Physiology
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The following parameters will be used to asses the microcirculatory reaction after provocation:<br>
Flow in the capillary, venules and arterioles can be scored semi quantitatively or quantitatively:<br>
1. Semi quantitative scoring:
(0 = no flow, 1 = intermittent flow, 2 = sluggish flow and 3 = continuous flow);<br>
2. Quantitative scoring:
(velocity, flow, diameter, length, density).
Achtergrond van het onderzoek
The nose, and in particular the nasal mucosa, is a very dynamic organ system. It combines olfactory and respiratory functions and acts as a first defence mechanism against pathogens. The nose maintains a rich neurovascular network to manage the different tasks of which the nasal microcirculation stands out in managing these very diverse physiological processes. However, little is known about abnormalities of the microcirculation and the role it may play in different nasal dysfunctions or disorders.
In this study we would like to assess the microcirculation of healthy subjects as well as to observe the expected of a widely used nasal spay: xylometazoline.
This over-the-counter availabele nasal spray works as a decongestent and is widely used.
As a sympathicomimeticum its main effect is vasocontriction. The aim is to visualize this reaction in healthy subjects using a double blind placebo controlled setting.
Doel van het onderzoek
Xylometazoline nasal spray realizes vasoconstricion in the nasal mucosa, which will be assessed and visualized using SDF imaging.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
The microcirculation of the nasal mucosa of healthy controls will assessed using a non invasive probe, diameter 0.5 cm, which will be placed in the nasal cavity, twice for a period of approximately 10 minutes. Images will be recorded to make off-line analysis possible. In between the two periods of recording/measuring, the healthy volunteers will get a provocation with xylometazoline nasal spray or placebo. After a few minutes the second measurement will be done to assess the possible differences in the microcirculation.
Publiek
Room A2-234,
P.O. Box 22660
W.J. Fokkens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663789
W.J.Fokkens@amc.nl
Wetenschappelijk
Room A2-234,
P.O. Box 22660
W.J. Fokkens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663789
W.J.Fokkens@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients with active allergic rhinitis, idiopathic rhinitis, chronic rhinosinusitis or nasal polyps;
2. Males or females aged over 18 years with no maximum age;
3. Approval of the patient’s physician;
4. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Smoking;
2. Severe cardiac or pulmonary disorder;
3. Peripheral vascular disease;
4. Medication:
systemic: â blockers, corticosteroids (local and systemic);
any local nasal treatment;
bronchodilatory inhalation medication for pulmonary diseases > 1000 ìg/day;
5. Cystic fibrosis, Immotile cilia syndrome, Rendu-Osler-Weber disease, vasculitis;
6. Cocaine and/or alcohol abuse.
Opzet
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In overige registers
Register | ID |
---|---|
NTR-new | NL710 |
NTR-old | NTR719 |
Ander register | : N/A |
ISRCTN | ISRCTN67264420 |