Visualisation of the microcirculation of the nasal mucosa in vivo in different nasal disorders, using sidestream dark-field imaging

ISRCTN	ISRCTN67264420
DOI	https://doi.org/10.1186/ISRCTN67264420
Protocol serial number	NTR719
Sponsor	Academic Medical Centre (AMC) (The Netherlands)
Funder	Academic Medical Centre (AMC) (The Netherlands)

Submission date: 21/07/2006
Registration date: 21/07/2006
Last edited: 05/11/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof W J Fokkens
Scientific

Academic Medical Centre (AMC)
Department of Otorhinolaryngology, Room A2-234
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 566 3789
Email	W.J.Fokkens@amc.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ViMiNa
Study objectives	Xylometazoline nasal spray relieves vasoconstriction in the nasal mucosa, which will be assessed and visualised using sidestream dark-field (SDF) imaging.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Nasal disorder
Intervention	The microcirculation of the nasal mucosa of healthy controls will be 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 or measuring, the healthy volunteers will get a provocation with xylometazoline nasal spray or placebo. After a few minutes, a second measurement will be taken to assess possible differences in the microcirculation.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Xylometazoline
Primary outcome measure(s)	The following parameters will be used to assess 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 3 = continuous flow 2. Quantitative scoring: velocity, flow, diameter, length, density
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	20
Key inclusion criteria	1. Patients with active allergic rhinitis, idiopathic rhinitis, chronic rhinosinusitis or nasal polyps 2. Males or females aged over 18 years; no maximum age 3. Approval from the patient's physician 4. Written informed consent
Key exclusion criteria	1. Smoker 2. Severe cardiac or pulmonary disorder 3. Peripheral vascular disease 4. Medication: systemic alpha-blockers, corticosteroids (local and systemic), any local nasal treatment, bronchodilatory inhalation medication for pulmonary diseases >1000 µg/day 5. Cystic fibrosis, immotile cilia syndrome, Rendu-Osler-Weber disease, vasculitis 6. Cocaine and/or alcohol abuse
Date of first enrolment	01/07/2006
Date of final enrolment	01/12/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre (AMC)

Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan