ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001504303

Ethics application status

Approved

Date submitted

16/10/2017

Date registered

25/10/2017

Date last updated

5/09/2019

Date data sharing statement initially provided

5/09/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Tympanometry in the Emergency Management of Children with Acute Otitis Media

Scientific title

Efficacy of Tympanometry in the Emergency Management of Children with Acute Otitis Media

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

AOM (Acute Otitis Media)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute Otitis Media

Condition category

Condition code

Ear

Other ear disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Children presenting the the Caboolture Hospital Emergency Department with Acute Otitis Media will be randomly assigned to either of two groups, the standard care group or the standard care plus tympanometry group.

The standard care group will undergo triage, assessment and treatment as per the Queensland Health guidelines for the care and management of children with otitis media (document ID: CHQ-GDL-00710). This involves determining a clinical diagnosis of Acute Otitis Media based on acute onset of signs and symptoms (<48 hrs), signs of middle ear inflammation and middle ear effusion. Management usually involves analgesia and either a 'watch and wait' approach to see if symptoms resolve spontaneously, or antibiotic prescription if the child has systemic features (high fever >39 degrees celsius, vomiting, lethargy). Antibiotics may also be required if:
Age <2 years with bilateral AOM
Symptoms persisting past 48 hours
Severe symptoms (fever>39 degrees celsisus, moderate to severe otalgia)
Evidence of perforation
higher risk of complications (mastoiditis, chronic suppurative otitis media), immunodeficiency, uncertain access to follow up.

Participants allocated to the standard care plus tympanometry group (intervention group) will have tympanometry, an objective test of middle ear function, performed in addition to the standard care assessments in the emergency department once triaged. Tympanometry varies air pressure inside the External ear canal from +100 daPa to -300 daPa and records the effect on tympanic membrane mobility. It has clinical validity in identifying normal vs abnormal middle ear function and will be performed on each participant in the tympanometry group by a registered clinical Audiologist with over 15 years experience. It is expected it will only need to be performed once per ear to obtain accurate results.

The aim of this study is to determine if providing tympanometry can improve diagnosis and subsequent management of Acute Otitis Media in young children.

Intervention code [1]

Diagnosis / Prognosis

Intervention code [2]

Treatment: Other

Comparator / control treatment

Children not assigned to the tympanometry group will receive the standard care processes usually provided to children with Acute Otitis Media at the Caboolture Hospital Emergency Department.

The standard care process involves triage, assessment and treatment as per the Queensland Health guidelines for the care and management of children with otitis media (document ID: CHQ-GDL-00710). This involves determining a clinical diagnosis of Acute Otitis Media based on acute onset of signs and symptoms (<48 hrs), signs of middle ear inflammation and middle ear effusion. Management usually involves analgesia and either a 'watch and wait' approach to see if symptoms resolve spontaneously, or antibiotic prescription if the child has systemic features (high fever >39 degrees celsius, vomiting, lethargy). Antibiotics may also be required if:
Age <2 years with bilateral AOM
Symptoms persisting past 48 hours
Severe symptoms (fever>39 degrees celsisus, moderate to severe otalgia)
Evidence of perforation
higher risk of complications (mastoiditis, chronic suppurative otitis media), immunodeficiency, uncertain access to follow up.

Control group

Active

Outcomes

Primary outcome [1]

Percentage of children diagnosed with Acute Otitis Media, as recorded in the child's medical record.

Timepoint [1]

The medical records for each child will be updated with the current diagnosis before the child is discharged from the emergency department. This will occur within 3 hours of admission to the emergency department.

Secondary outcome [1]

A comparison of Length Of Stay times for children between the two groups. This will be determined by the Emergency Department records and the child's medical records.

Timepoint [1]

This outcome will be recorded once the child attends the emergency department, when they are triaged and at completion of the visit/discharge from ED. Results for all children will be analysed for statistical significance at 12 months after randomisation, during the data analysis phase.

Secondary outcome [2]

Percentage of children prescribed antibiotics for Acute Otitis Media. This will be determined by electronic chart review after the child has been discharged from the ED.

Timepoint [2]

Data will be collected after the child has been discharged from the ED and within 1 week.

Eligibility

Key inclusion criteria

Children aged between 6 months and 5 years of age attending the Caboolture Hospital Emergency Department within normal office hours with suspected uncomplicated Acute Otitis Media.

Minimum age

6 Months

Maximum age

5 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria include children outside the age range, recent antibiotic usage within 30 days and/or systemic features necessitating antibiotic treatment (including septicaemia, meningitis, pneumonia or urinary tract infection). Children will also be excluded if they have insitu grommets, chronic middle ear pathology and genetic conditions with anatomic abnormalities, include Downs Syndrome, cleft palate and immune deficiencies.

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation involved contacting the holder of the allocation schedule (Chief investigator) who is “off-site” or at central administration site.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

To detect a > 30% difference in the two groups, using a 2 –tailed alpha =.05 and a power of .80, each group requires 24 participants per condition. Data analysis will use a 2 tailed chi² and t – test to compare the antibiotic prescription rate, diagnosis and length of stay times in the ED between the two conditions.

Recruitment

Recruitment status

Withdrawn

Reason for early stopping/withdrawal

Lack of funding/staff/facilities
Participant recruitment difficulties

Date of first participant enrolment

Anticipated

1/12/2017

Actual

Date of last participant enrolment

Anticipated

3/12/2018

Actual

Date of last data collection

Anticipated

3/12/2018

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Caboolture Hospital - Caboolture

Recruitment postcode(s) [1]

4510 - Caboolture

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Metro North Hospital and Health Service

Address [1]

Caboolture Hospital
McKean St
Caboolture Qld 4510

Country [1]

Australia

Primary sponsor type

Hospital

Name

Caboolture Hospital

Address

McKean St
Caboolture Qld 4510

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children's Health Queensland Hospital and Health Service Human Research Ethics Committee

Ethics committee address [1]

Level 7, Centre for Children's Health Research
Lady Cilento Children's Hospital
62 Graham St
South Brisbane Qld 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/07/2017

Approval date [1]

03/10/2017

Ethics approval number [1]

HREC/17/QRCH/164

Summary

Brief summary

This study seeks to determine if Tympanometry is beneficial in the care of children with suspected AOM when using the Queensland Health management guidelines. Currently, AOM is diagnosed through a combination of case history, body temperature and otoscopic examination to ascertain the presence of acute middle ear infection. Otoscopy can be difficult to perform on a distressed child and is insufficiently precise to diagnose AOM by itself. The objective information provided by Tympanometry can exclude normal from abnormal middle ear function, providing evidence for a differential diagnosis in these situations. It is anticipated this information will support Physicians to consider alternative management strategies to routine antibiotic prescription when faced with these presentations.

The primary goal of the research project is to determine if providing Tympanometry reduces the antibiotic prescription rate in children attending the Emergency Department with suspected AOM. This will be determined by comparing the antibiotic prescription rate between two groups of children, those who receive the standard care as per the management guidelines, and those who receive the standard care plus tympanometry testing. Research by Spiro et al., showed 40% of children were over-diagnosed with Acute Otitis Media in the absence of middle ear dysfunction/effusion. Identifying children who do not have a middle ear infection will result in a reduction in the percentage of children presenting with suspected AOM that are diagnosed with AOM and in the amount of antibiotics prescribed. 

Secondary analysis will determine if there is a difference in the length of stay times between the two groups. The results from this study will provide clinical data to support Queensland Health guidelines in the management of this patient group. It is anticipated the results from this study will support the implementation of Tympanometry in the ED for the management of children with AOM by reducing unnecessary antibiotic prescribing and reducing the length of stay in the ED.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/373823-AOM protocol V1.0.doc (Protocol)

Attachments [2]

/AnzctrAttachments/373823-Parent-Guardian Consent Form V2.doc (Participant information/consent)

Attachments [3]

/AnzctrAttachments/373823-Patient information Sheet V1.doc (Participant information/consent)

Attachments [4]

/AnzctrAttachments/373823-approval 031017.rtf (Ethics approval)

Contacts

Principal investigator

Name

Dr Clive Holloway

Address

Allied Health Department
Caboolture Hospital
McKean St
Caboolture Qld 4510

Country

Australia

Phone

+61 7 5433 8625

Fax

clive.holloway@health.qld.gov.au

Contact person for public queries

Name

Clive Holloway

Address

Caboolture Hospital
McKean St
Caboolture Qld 4510

Country

Australia

Phone

+61 7 5433 8625

Fax

clive.holloway@health.qld.gov.au

Contact person for scientific queries

Name

Clive Holloway

Address

Caboolture Hospital
McKean St
Caboolture Qld 4510

Country

Australia

Phone

+61 7 5433 8625

Fax

clive.holloway@health.qld.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

No data - Recruitment not successful.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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