Condition category
Not Applicable
Date applied
24/02/2014
Date assigned
11/04/2014
Last edited
11/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 patient’s 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Moustafa A. Moustafa

ORCID ID

Contact details

Alnasr street
Smouha
Alboroug Buildings
Building 5
Flat 701
Alexandria
21615
Egypt
+20 (0) 1222373407
m.3abdelaziz@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0301334

Study information

Scientific title

Effect of neck collar on upper airway size in children sedated with propofol during magnetic resonance imaging

Acronym

Study hypothesis

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

Ethics Committee of the Alexandria Main University Hospitals, 16/6/2011, IRB NO: 00007555-FWA NO:00015712

Study design

Prospective randomized single-blind cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/12/2012

Overall trial end date

01/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients scheduled for magnetic resonance imaging of the brain
2. Age from 2 to 4 years
3. ASA class I – III

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

Any patient with hydrocephalus, tonsillitis and upper or lower respiratory disease

Recruitment start date

01/12/2012

Recruitment end date

01/12/2013

Locations

Countries of recruitment

Egypt

Trial participating centre

Alnasr street
Alexandria
21615
Egypt

Sponsor information

Organisation

Alexandria Faculty of Medicine (Egypt)

Sponsor details

Champelion street
Azarita
Alexandria
21256
Egypt
+20 (0) 1287740750
alexmedethics@yahoo.com

Sponsor type

University/education

Website

http://www.alexu.edu.eg/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Egypt)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes