Neck collar for pediatric MRI sedation
| ISRCTN | ISRCTN67090623 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67090623 |
| Secondary identifying numbers | 0301334 |
- Submission date
- 24/02/2014
- Registration date
- 11/04/2014
- Last edited
- 11/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Children require deep sedation when undergoing magnetic resonance imaging (MRI) scans. General anesthetics such as propofol cause airway narrowing and, in some cases, complete blockage of the airway. When you lose consciousness your head moves spontaneously, obstructing the airway. A device such as a neck support collar may help keep the airway open during sedation. The aim of this study is to assess the effect of a soft neck collar on the airway using an MRI scan.
Who can participate?
Patients aged from 2 to 4 years scheduled for an MRI scan of the brain.
What does the study involve?
Patients were sedated with propofol and underwent MRI scanning of the neck region. The procedure was carried out twice, first with the patients head in a neutral position on the MRI table, then with the patient wearing a soft neck collar.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Alexandria Faculty of Medicine (Egypt).
When is the study starting and how long is it expected to run for?
The study ran from December 2012 to December 2013.
Who is funding the study?
Investigator initiated and funded.
Who is the main contact?
Moustafa Abdelaziz Moustafa
m.3abdelaziz@hotmail.com
Contact information
Scientific
Alnasr street
Smouha
Alboroug Buildings
Building 5
Flat 701
Alexandria
21615
Egypt
| Phone | +20 (0) 1222373407 |
|---|---|
| m.3abdelaziz@hotmail.com |
Study information
| Study design | Prospective randomized single-blind cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of neck collar on upper airway size in children sedated with propofol during magnetic resonance imaging |
| Study objectives | Assess the effect of a soft neck collar application in children sedated with propofol on the upper airway size and patency using magnetic resonance imaging. |
| Ethics approval(s) | Ethics Committee of the Alexandria Main University Hospitals, 16/6/2011, IRB NO: 00007555-FWA NO:00015712 |
| Health condition(s) or problem(s) studied | Pediatric MRI sedation |
| Intervention | Patients were sedated with propofol 1 mg.kg-1, then 50-100 µg.kg-1.min-1. Magnetic resonance images of the neck region, from skull-base down to the subglottic region, were obtained using a dedicated head-neck coil. A three-plane gradient echo scout view was acquired to visualize the gross anatomic details and help to plane for our main sequence, a T1 3D FFE axial sequence extending from the nasopharyngeal roof down to the subglottic region. The sequence was done before and after application of the neck collar. The first head position was determined by MRI to be neutral. The soft neck collar was then applied, maintaining neck extension. |
| Intervention type | Other |
| Primary outcome measure | Upper airway size measured during the MRI procedure |
| Secondary outcome measures | Incidence and frequency of complications measured during the procedure and until the patient is fully awake and discharged |
| Overall study start date | 01/12/2012 |
| Completion date | 01/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 4 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Patients scheduled for magnetic resonance imaging of the brain 2. Age from 2 to 4 years 3. ASA class I III |
| Key exclusion criteria | Any patient with hydrocephalus, tonsillitis and upper or lower respiratory disease |
| Date of first enrolment | 01/12/2012 |
| Date of final enrolment | 01/12/2013 |
Locations
Countries of recruitment
- Egypt
Study participating centre
21615
Egypt
Sponsor information
University/education
Champelion street
Azarita
Alexandria
21256
Egypt
| Phone | +20 (0) 1287740750 |
|---|---|
| alexmedethics@yahoo.com | |
| Website | http://www.alexu.edu.eg/ |
"ROR" |
https://ror.org/00mzz1w90 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
