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van CCT (UK)

van CCT (UK)

Visualization of the microcirculation of the nasal mucosa in vivo in different nasal disorders, using Sidestream Dark-Field (SDF) imaging.

- candidate number2154
- NTR NumberNTR719
- Date ISRCTN created21-jul-2006
- date ISRCTN requested19-jul-2006
- Date Registered NTR30-jun-2006
- Secondary IDsN/A 
- Public TitleVisualization of the microcirculation of the nasal mucosa in vivo in different nasal disorders, using Sidestream Dark-Field (SDF) imaging.
- Scientific TitleVisualization of the microcirculation of the nasal mucosa in vivo in different nasal disorders, using Sidestream Dark-Field (SDF) imaging.
- hypothesisXylometazoline nasal spray realizes vasoconstricion in the nasal mucosa, which will be assessed and visualized using SDF imaging.
- Healt Condition(s) or Problem(s) studiedNasal disorders, Microcirculation
- Inclusion criteria1. 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 patientís physician;
4. Written informed consent.
- Exclusion criteria1. Smoking;
2. Severe cardiac or pulmonary disorder;
3. Peripheral vascular disease;
4. Medication:
systemic: ‚ blockers, corticosteroids (local and systemic);
any local nasal treatment;
bronchodilatory inhalation medication for pulmonary diseases > 1000 žg/day;
5. Cystic fibrosis, Immotile cilia syndrome, Rendu-Osler-Weber disease, vasculitis;
6. Cocaine and/or alcohol abuse.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2006
- planned closingdate1-dec-2006
- Target number of participants20
- InterventionsThe 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.
- Primary outcomeThe following parameters will be used to asses the microcirculatory reaction after provocation:
Flow in the capillary, venules and arterioles can be scored semi quantitatively or quantitatively:
1. Semi quantitative scoring: (0 = no flow, 1 = intermittent flow, 2 = sluggish flow and 3 = continuous flow);
2. Quantitative scoring: (velocity, flow, diameter, length, density).
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- Sponsor/Initiator Academic Medical Center (AMC), Department of Otorhinolaryngology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD30-jun-2006 - 14-sep-2009

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