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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05183477
Other study ID # 2021-02140
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 17, 2021
Est. completion date December 31, 2027

Study information

Verified date December 2023
Source Ente Ospedaliero Cantonale, Bellinzona
Contact Laura Uccella, MD
Phone 0041918116657
Email laura.uccella@eoc.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a mono centric, prospective, randomised trial on the implementation and assessment of a shortened pathway for mono-trauma of the wrist and suspected fracture of distal radius and/or ulna and/or scaphoid bone.


Description:

Patients will be randomised into two groups: fast track and normal pathway. At the arrival in the Emergency Department a triage will be performed. In case of met inclusion criteria the patient will sign the informed consent and will be randomised in one of the two study groups. The fast track group will be straightforwardly evaluated for absence of exclusion criteria (in case of exclusion criteria present the investigators will follow the normal pathway and the patient will not be included in the study). Then, patients will be assessed with an ad hoc checklist and then sent for x-ray performance, if necessary. After the x-ray the patients will be examined by an emergency physician that will have the opportunity to request new x-ray views if necessary. The normal pathway group will go straight to medical examination as soon as possible, depending on waiting times in the Emergency Department. Investigators will collect anagraphical data, waiting times, time to x-ray, overall length of stay in the Emergency Department, patients' and staff's satisfaction for the two groups.


Recruitment information / eligibility

Status Recruiting
Enrollment 712
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adults patients presenting at the emergency dept with suspected scaphoid or wrist fracture - monotrauma - written informed consent Exclusion Criteria: - patients younger than 18 yr - pregnant women - either vascular or neural impairment - signs of open fracture - multiple trauma patient

Study Design


Intervention

Other:
fast track
short cut for the request of xrays directly at triage
normal pathway
x-ray would be required according to doctor's clinical evaluation.

Locations

Country Name City State
Switzerland Ospedale Regionale di Lugano - ORL Lugano Ticino

Sponsors (1)

Lead Sponsor Collaborator
Ente Ospedaliero Cantonale, Bellinzona

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Chudleigh J. Nurse requested X-rays in A&E department. Emerg Nurse. 2004 Feb;11(9):32-6. doi: 10.7748/en2004.02.11.9.32.c1146. No abstract available. — View Citation

Mallee WH, Walenkamp MMJ, Mulders MAM, Goslings JC, Schep NWL. Detecting scaphoid fractures in wrist injury: a clinical decision rule. Arch Orthop Trauma Surg. 2020 Apr;140(4):575-581. doi: 10.1007/s00402-020-03383-w. Epub 2020 Mar 3. — View Citation

Streppa J, Schneidman V, Biron AD. Requesting wrist radiographs in emergency department triage: developing a training program and diagnostic algorithm. Adv Emerg Nurs J. 2014 Jan-Mar;36(1):62-77. doi: 10.1097/TME.0000000000000005. — View Citation

van den Brand CL, van Leerdam RH, van Ufford JH, Rhemrev SJ. Is there a need for a clinical decision rule in blunt wrist trauma? Injury. 2013 Nov;44(11):1615-9. doi: 10.1016/j.injury.2013.07.006. Epub 2013 Jul 31. — View Citation

Walenkamp MM, Bentohami A, Slaar A, Beerekamp MS, Maas M, Jager LC, Sosef NL, van Velde R, Ultee JM, Steyerberg EW, Goslings JC, Schep NW. The Amsterdam wrist rules: the multicenter prospective derivation and external validation of a clinical decision rule for the use of radiography in acute wrist trauma. BMC Musculoskelet Disord. 2015 Dec 18;16:389. doi: 10.1186/s12891-015-0829-2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary number of x rays requested the number of xray requested From admission to discharge, up to 2.5 hours
Secondary waiting time before examination From admission to discharge, up to 2.5 hours
Secondary waiting time before xray From admission to discharge, up to 2.5 hours
Secondary total length of stay in the emergency department From admission to discharge, up to 2.5 hours
Secondary patient's satisfaction Patients' satisfaction will be tested with the help of the brief emergency department patient satisfaction scale (BEPSS). The questionnaire consists of 20 questions and for each item, a response scale form 1 (completely disagree) to 4 (completely agree) is used. From admission to discharge, up to 2.5 hours
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