The Use of a Mock MRI Scanner for Reducing the Use of Anesthesia in Children Undergoing Clinical MRI Scans

Magnetic Resonance Imaging Clinical Trial

Official title:

The Use of a Mock MRI Scanner for Reducing the Use of Anesthesia in Children Undergoing Clinical MRI Scans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02630342
• Other study ID #: REB-15-368
• Status: Recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: September 2019

Study information

• Verified date: May 2019
• Source: University of Calgary
• Contact: Catherine Lebel, PhD
• Phone: 1-403-955-7241
• Email: catherine.lebel[@]albertahealthservices.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Diagnostic Magnetic Resonance (MR) imaging procedures can be stressful for children and parents. Patients must lie still during the procedure to provide diagnostic quality images. Children <7 years are often sedated or given general anesthesia (GA) for imaging procedures. The high cost of GA and its associated risks motivate the search for alternatives. The overall goal of this study is to systematically investigate whether training on the mock MR scanner reduces the need for GA during Magnetic Resonance Imaging (MRI) scans in children.

160 participants scheduled for diagnostic MRI scans at Alberta Children's Hospital (ACH) will be recruited to undergo different training methods for MRI scanning. Group 1 will be sent links to online videos about MRI, audio files with scanner noises, and a children's book about MR scans, to prepare at home. Group 2 will receive training materials and visit the ACH to review them with the research team, but will not use the mock scanner. Group 3 will receive training materials and visit the ACH for training on the mock MR scanner. Visits to the mock scanner for Group 3 will include practice lying down, staying still, wearing headphones, and watching a movie on the mirror system. During and after training sessions, the investigators will collect data on total time spent preparing (mock scanner or other), the child's feelings of stress/worry before and after visit, and head motion during mock MRI session (if applicable).

Subjects will be scheduled for a clinical scan without GA and a follow-up clinical scan with GA (to be cancelled if the first scan is successful). Scan success will be determined by a radiologist. Measures of scan success, quality ratings for each scan, children's feelings of stress/worry related to the MRI, and saliva samples to measure cortisol and salivary alpha amylase, will be gathered at the clinical scan. An ANOVA will be used to compare different training groups.

A clinical group of 35 neuro-oncology patients aged 3-7 years of age that undergo frequent MRI scans will also undergo staged preparation by child life specialists using the mock scanner. The age at which they are able to complete MRI without general anesthesia will be compared with a retrospective control group in the 3 years prior. Measures to be used for this group are the same (with the exception of saliva samples). T test and Kaplan- Meier analysis will be used to compare age at which MRI can be performed awake.

Description:

Diagnostic MR procedures can be scary and stressful for children and parents. Because patients must lie still during the procedure to provide diagnostic quality images, young children (typically <7 years) and others not expected to comply are often sedated or given general anesthesia (GA) for imaging procedures. However, the high cost of GA and its associated risks motivate the search for alternatives. Previous reports demonstrate that preparation (including using a mock MR scanner) reduces anxiety and increases compliance for clinical and research MRI procedures without GA. However, systematic studies of the advantages of a mock MR scanner versus other training methods are lacking. Furthermore, while reducing the use of GA is desirable, repeated unsuccessful scanning procedures are also costly, so identifying factors that predict success for diagnostic MR procedures is important to effectively allocate resources.

Aims

The overall goal of this study is to systematically investigate whether training on the mock MR scanner reduces the need for GA during MRI scans in children. There are three specific aims:

1. Determine whether pre-scan training allows children to have successful diagnostic MRI scans without general anesthesia.

2. Examine the effects of different types of pre-scan training on reducing anxiety and stress in children and their parents related to diagnostic MRI.

3. Determine whether mock scanner training can lower the age at which neuro-oncology patients are able to complete a full diagnostic MRI without anesthesia compared with historic controls.

Patient name, date of birth, and hospital identification number are necessary to perform chart review and access diagnostic images. All identifying information will be removed prior to data analysis.

The following data will be collected/recorded for each participant at enrollment:

1. Study number

2. Sex

3. Age at time of scan(s)

4. Type of diagnostic scans requested

5. Parent report on overall stress

6. Parent proxy measures of child stress/worry (PedsQL)

7. Parent predictions of child success on MRI

8. (Aim 3 only) Primary Oncology Diagnosis: i) Site ii) Histology

9. (Aim 3 only) Treatment mode i) Surgery ii) Chemotherapy iii) Radiotherapy

Training Sessions

For Aims 1 and 2, participants will be randomly assigned to one of three training groups. Group 1 will be sent links to online videos about MRI, audio files with scanner noises, and a children's book about MR scans, to prepare at home. Group 2 will receive training materials and visit the ACH to review them with the research team, but will not use the mock scanner. Group 3 will receive training materials and visit the ACH for training on the mock MR scanner. Visits to the mock scanner for Group 3 will include practice lying down, staying still, wearing headphones, and watching a movie on the mirror system. The Child Life Specialist will talk with the child and his/her family about the experience, and allow them up to 1 hour of practice time on the mock scanner.

For Aim 3, all participants will receive training on the mock scanner similar to group 3 with the difference being Child Life Specialists will utilize a goal based preparation of 3 X 20 minute sessions to coincide with other visits to the hospital.

All participants will be booked for one MR scan without GA and one with GA a week later in case the first scan fails.

The following data will be collected during/after training sessions:

1. Total time spent preparing (mock scanner or other)

2. Child's feelings of stress/worry before and after visit (PedsQL)

3. Head motion during mock MRI session (if applicable)

Diagnostic MRI Sessions

The following information will be recorded for each child's MRI scan:

1. Date of MRI.

2. Child's age at time of scanning.

3. Scan success without anesthesia (pass/fail)

4. Number of sequences requiring repeating

5. Total scan length (mins)

6. Sum of individual scan sequence times (mins)

7. Quality of images, as determined by a pediatric neuro-radiologist and graded as Excellent (no motion artifact ), Good (minimal motion artifact ); Acceptable (motion artifact; but satisfactory to answer the clinical question); Unacceptable (significant motion artifact ; unable to answer the clinical question)

8. Parent proxy measures of child stress ( PedsQL )

9. Child's stress/worry (PedsQL)

10. (Aims 1 and 2) Saliva sample to measure cortical and salivary alpha amylase before and after diagnostic MR scan

If images are deemed suitable for clinical diagnosis, the subsequent GA booking will be cancelled.

No raw images will be retained for any patients outside of their hospital record.

For Aim 3 prospective data, the above information will be recorded at each scanning session until the patient is able to complete the entire scan without anesthesia.

For Aim 3 retrospective data: The patient's hospital identification number will be used to identify MRI scans performed on that patient in the 3 years prior to the study. The MRI report will be cross referenced with the department of anesthesia electronic database to determine the date and thereby the age at which MRI without GA was able to be performed. In the case where the MRI report states that scan was performed under GA but no electronic record of GA is present the paper chart will be reviewed to determine if GA was performed. If The MRI scan report does not specify that GA was performed and an anesthesia record for the MRI exists then scan will be considered to have been performed under GA.

Statistical Plan

An ANOVA will be used to evaluate group differences on scanning success measures. Additional analyses will focus on correlations between scan successes and age, sex, measures of child/parent stress, cortisone, salivary alpha amylase, and training session compliance.

Aim 3 will also explicitly test differences in the mean age in months at which neuro-oncology patients were able to successfully complete the diagnostic MRI without anesthesia in the groups with and without mock scanner training. These will be compared utilizing T-test and Kaplan-Meier Analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

• Elective MRI scans

• No previous Diagnostic MRI without GA

• Would normally receive GA for diagnostic MRI

• No significant developmental delay

• Ability to understand English for groups 1,2 and 3.

• For neuro-oncology group: Ability of accompanying parent and/or child to communicate in English with regular exposure of the child to the English language

• For Neuro-oncology subgroup:a diagnosis of primary brain tumor under the care of neuro-oncology at Alberta Children's Hospital

Exclusion Criteria:

• Inability to understand consent form

• Urgent Scans (insufficient time to prepare)

• Previous diagnostic MRI without the need for general anesthesia

• Fast brain MRI (single sequence for sole purpose of determining size of cerebrospinal fluid (CSF) spaces)

Related Conditions & MeSH terms

• Magnetic Resonance Imaging

Intervention

Behavioral:
• Mock MRI scanner
Using a mock scanner for preparation for MRI
• Preparation materials
links to online videos about MRI, audio files with scanner noises, and a childrens book about MRI scan.
• Child Life Specialist preparation
Child Life Therapist will coordinate the prepartion of the child
• Review Preparation Materials
Review of preparation materials at the hospital with member of research team

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Alberta Children's Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (10)

Barnea-Goraly N, Weinzimer SA, Ruedy KJ, Mauras N, Beck RW, Marzelli MJ, Mazaika PK, Aye T, White NH, Tsalikian E, Fox L, Kollman C, Cheng P, Reiss AL; Diabetes Research in Children Network (DirecNet). High success rates of sedation-free brain MRI scanning in young children using simple subject preparation protocols with and without a commercial mock scanner--the Diabetes Research in Children Network (DirecNet) experience. Pediatr Radiol. 2014 Feb;44(2):181-6. doi: 10.1007/s00247-013-2798-7. Epub 2013 Oct 6. — View Citation

Carter AJ, Greer ML, Gray SE, Ware RS. Mock MRI: reducing the need for anaesthesia in children. Pediatr Radiol. 2010 Aug;40(8):1368-74. doi: 10.1007/s00247-010-1554-5. Epub 2010 Feb 26. — View Citation

de Amorim e Silva CJ, Mackenzie A, Hallowell LM, Stewart SE, Ditchfield MR. Practice MRI: reducing the need for sedation and general anaesthesia in children undergoing MRI. Australas Radiol. 2006 Aug;50(4):319-23. — View Citation

de Bie HM, Boersma M, Wattjes MP, Adriaanse S, Vermeulen RJ, Oostrom KJ, Huisman J, Veltman DJ, Delemarre-Van de Waal HA. Preparing children with a mock scanner training protocol results in high quality structural and functional MRI scans. Eur J Pediatr. 2010 Sep;169(9):1079-85. doi: 10.1007/s00431-010-1181-z. Epub 2010 Mar 13. — View Citation

Hallowell LM, Stewart SE, de Amorim E Silva CT, Ditchfield MR. Reviewing the process of preparing children for MRI. Pediatr Radiol. 2008 Mar;38(3):271-9. Epub 2007 Dec 15. — View Citation

Lueken U, Muehlhan M, Evens R, Wittchen HU, Kirschbaum C. Within and between session changes in subjective and neuroendocrine stress parameters during magnetic resonance imaging: A controlled scanner training study. Psychoneuroendocrinology. 2012 Aug;37(8):1299-308. doi: 10.1016/j.psyneuen.2012.01.003. Epub 2012 Feb 5. — View Citation

Pressdee D, May L, Eastman E, Grier D. The use of play therapy in the preparation of children undergoing MR imaging. Clin Radiol. 1997 Dec;52(12):945-7. — View Citation

Raschle NM, Lee M, Buechler R, Christodoulou JA, Chang M, Vakil M, Stering PL, Gaab N. Making MR imaging child's play - pediatric neuroimaging protocol, guidelines and procedure. J Vis Exp. 2009 Jul 30;(29). pii: 1309. doi: 10.3791/1309. — View Citation

Sherman SA, Eisen S, Burwinkle TM, Varni JW. The PedsQL Present Functioning Visual Analogue Scales: preliminary reliability and validity. Health Qual Life Outcomes. 2006 Oct 4;4:75. — View Citation

Tyc VL, Fairclough D, Fletcher B, Leigh L, Mulhern RK. Children's distress during magnetic resonance imaging procedures. Child Health Care. 1995 Winter;24(1):5-19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of Diagnostic Scan	Whether child is able to complete a diagnostic MRI scan without general anesthesia	Immediate: on the date of scheduled MRI
Primary	Neuro-oncology Age of completion of MRI without GA	Determine the age at which neuro-oncology patients can complete a full diagnostic MRI without requiring general anesthesia	3 years
Secondary	Quality of scan Quality of MRI for diagnostic purposes	Ability to use scan for diagnostic purpose	Immediate: on the date of scheduled MRI
Secondary	Time taken to complete diagnostic MRI	Time in minutes	Immediate: on the date of scheduled MRI
Secondary	Number of scan sequences that require repeating	Number of scans sequences that need repeating	Immediate: on the date of scheduled MRI
Secondary	Childs feelings of stress	Using Peds QL child version and parent proxy version to quantify stress	Immediate: on the date of scheduled MRI
Secondary	Salivary stress hormone levels (cortisol & alpha amylase)	Salivary stress hormones will be measured for training groups 1,2 and 3	Immediate: on the date of scheduled MRI
Secondary	Compliance with training	recording the amount of time preparation took	2 weeks