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Bedside Ultrasound study for appendicitis and its utility in the emergency department (Australian ED setting)

Diagnostic Accuracy of Point of Care Ultrasound (POCUS) for appendicitis in the Paediatric Population in an Australian ED Setting.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000109505
Enrollment
60
Registered
2024-02-08
Start date
2023-08-13
Completion date
Unknown
Last updated
2024-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary aim of the study is to determine the accuracy of POCUS, performed in the paediatric ED by ED physicians, for diagnosis of appendicitis. The study population will consist of patients 5-18 years old presenting to the WCH ED with suspicion of appendicitis over a 9 month period, with POCUS performed by 7 different ED physicians with differing levels of experience. Thus the primary interest are overall measures of diagnostic accuracy of POCUS when performed in the ED setting with formal scans.

Interventions

Participants will be identified by ED doctor's (Consultants, Registrars and RMO) on initial clinical exam if they meet the inclusion criteria of the study. Patients would only be approached for POCUS study when POCUS-certified clinicians are on shift. Initial doctor seeing the patient (intern, Resident Medical Officer (RMO), Registrar, other non-trained Consultants) would start off the data collection form based on history and clinical exam. Information about the participation information would

Participants will be identified by ED doctor's (Consultants, Registrars and RMO) on initial clinical exam if they meet the inclusion criteria of the study. Patients would only be approached for POCUS study when POCUS-certified clinicians are on shift. Initial doctor seeing the patient (intern, Resident Medical Officer (RMO), Registrar, other non-trained Consultants) would start off the data collection form based on history and clinical exam. Information about the participation information would be handed out at this point to give participants an opportunity to read and understand. Analgesia would be ensured prior to scan, POCUS-certified physician will then approach the patient or their guardian/caregiver/parent to discuss potential study involvement and to seek verbal consent. There are two sets of clinicians performing the bedside ultrasound: accredited and nonaccredited. The accredited clinicians would perform bedside scans and if patients are positive for appendicitis, they would be referred to Surgeons directly. If the results are equivocal (meaning that appendix is not fully visualised) or negative, then they would arrange a subsequent formal ultrasound. Non accredited clinicians performing POCUS will only perform bedside POCUS after verbal consent and all the bedside scans is followed up by formal scans. If at any point, the patient is uncomfortable and does not wish to have POCUS performed, the bedside POCUS exam would stop, and the patient’s concerns will be addressed. POCUS findings will be documented in the proforma. All Bedside scans will be done within 30min and opportunistically. Comparison would be made with subsequent RADUS scans (reported by the consultant Radiologist). The RADUS will be assessed from the Picture Archiving and Communications system (PACS) and findings would be recorded as either appendicitis, not appendicitis or equivocal. Additional data collected about the ED visit will include laboratory findings .. If appendicectomy is done, then the histo-pathological findings will be searched from the OASICS software and compared to both scans performed (in some cases with 1 bedside scan performed (for accredited clinicians)) POCUS performed positive scans would be compared with histopathology-proven appendicitis to deem true positive. The only key between bedside POCUS and RADUS would be the level of experience or skills, more detailed exam (by RADUS) as they would be looking for other causes of abdominal pain if not appendicitis and the quality of the ultrasound machines. All bedside scans would be done within 30 mins. Timings would be recorded. It would be done opportunistically while patients are waiting for formal scans. - In terms of training; All clinicians would get 1 hour of didactic teaching by an experienced sonographer 4 weeks before commencement. A practical session would follow with demonstration of POCUS technique on healthy volunteer patients. The first 10 scans done by non-accredited clinicians would be supervised by accredited clinicians in ED and data collected would be under the names of the accredited clinician's name. After the 10 initial scans supervised, the non-accredited clinicians would then perform scans individually. - Follow-up would be done for all patients who have had negative or equivocal ultrasound scan results by both physician and radiographer performed. They would be followed up via a text message in two weeks to check if they represented with abdominal pain again to any hospital after the initial hospital visit.

Sponsors

Women's and Children Hospital Network (WCHN)
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

-Children between the age 5 to 18 years -< 5 days duration (120 hours) of pain -Appendicitis is a differential diagnosis

Exclusion criteria

-Pain >120 hours duration - Previous bowel surgery, IBD, chronic pancreatitis, CF, sickle cell disease?? -Medical condition preventing the ability to obtain accurate history –nonverbal? - Language barrier -Transplant patients -Abdominal trauma within two weeks -Hemodynamic instability requiring resuscitation -Pregnancy - Testicular pain

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026