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Trial registered on ANZCTR


Registration number
ACTRN12622000626763
Ethics application status
Approved
Date submitted
12/04/2022
Date registered
28/04/2022
Date last updated
12/04/2023
Date data sharing statement initially provided
28/04/2022
Date results provided
12/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Blood sampling by venepuncture or intravenous cannula in moderate acuity emergency department patients.
Scientific title
Drawing blood from a peripheral intravenous cannula and its effect on cannula dwell time, phlebitis, and blood stream infection in moderate acuity emergency department patients: A randomised controlled study.
Secondary ID [1] 306907 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Individuals presenting to the emergency department with a health complaint and triaged as either a category 3 or category 4 patient. 326012 0
Condition category
Condition code
Emergency medicine 323318 323318 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adult patients (>18 years) admitted to the emergency department whose health condition requires a blood sample to be drawn, the insertion of a peripheral intravenous cannula (PIVC), and the possibility of hospital admission will be approached to participant in the study. On gaining written informed consent participants, will be randomised into either the interventional group where blood will only be sampled from the PIVC or randomised into the control group where the blood sample will be obtained only by venepuncture. Insertion of the PIVC will follow clinical practice guidelines observed at the study site by medical and nursing staff trained in performing the procedure. The choice of cannula gauge will be at the discretion of the treating doctor or nurse. Blood samples will be obtained in the emergency department by an experienced nurse having previously received training by a phlebotomist. Should the participant be admitted to a hospital ward and require additional blood samples the allocation of method of sampling will remain the same for the duration of life of the original PIVC and sampled by a trained phlebotomist, nurse, or doctor. A sign will be placed by the participant’s bedspace to remind ward staff to collect blood samples either by venepuncture and not through the PIVC if randomised to the control group or if randomised to the interventional group through the PIVC and not by venepuncture. All other aspects in the medical management of participants will not be affected by their involvement in the study. Follow-up of the PIVC will occur on day three post emergency department presentation. It is standard practice in Western Australia that after three days (72 hours) all PIVCs are removed and re-sited if there is a continuing need for PIVC access. The original PIVC inserted in the emergency department will be evaluated by the nurse or medical staff on duty for signs of cannula failure and the peripheral intravenous catheter assessment score (PIVAS) used to assess signs of phlebitis and infection. A member of the research team will check the history of the original PIVC on day three following the participant’s emergency department presentation. If discharged from the hospital before the follow-up period, the participant’s medical records will be recalled and PIVC documentation reviewed. Data will be collected from the participant’s medical notes and from data obtained during insertion about the PIVC including site of insertion, cannula gauge size and treatments received through the device.
Intervention code [1] 323356 0
Treatment: Devices
Intervention code [2] 323414 0
Prevention
Comparator / control treatment
The comparator or control treatment for the study is the standard practice of blood sampling by venepuncture. In the emergency department this will be performed by a nurse trained by a phlebotomist in the sampling of blood by venepuncture. In the event study participants require hospital admission, any additional blood samples that are required over three days as an inpatient whilst the original PIVC remains in situ, will be sampled by venepuncture by a trained phlebotomist, nurse, or doctor. A sign will be placed by the participant's bedspace to remind ward staff to collect blood samples either by venepuncture and not through the PIVC if randomised to the control group or if randomised to the interventional group through the PIVC and not by venepuncture.
Control group
Active

Outcomes
Primary outcome [1] 331062 0
Cannula dwell time assessed by audit of participant's medical notes.
Timepoint [1] 331062 0
Follow-up of study participants will occur after day three from emergency department presentation.
Primary outcome [2] 331142 0
Occurrence of phlebitis according to peripheral intravenous catheter assessment score (PIVAS).
Timepoint [2] 331142 0
Follow-up of study participants will occur after day three from emergency department presentation.
Primary outcome [3] 331143 0
Cannula-related blood stream infection according to examination of cannula insertion site, vital signs, and laboratory tests for bacterial infections.
Timepoint [3] 331143 0
Follow-up of study participants will occur after day three from emergency department presentation.
Secondary outcome [1] 408611 0
Cannula failure determined by evidence of dislodgement leading to extravasation or blockage of cannula lumen.
Timepoint [1] 408611 0
Cannula dwell time.
The cannula will be monitored continuously and the PIVAS reported during handover at the end of each nursing shift until its planned or unplanned removal.

Eligibility
Key inclusion criteria
Eligible participants include those triaged as either category 3 or 4 adult patients who present to the emergency department with a health complaint requiring a blood sample to be drawn and insertion of a PIVC. Recruitment of participants will only be made to patients who are conscious, able to give informed consent in writing, and whose medical management will not be affected by participation in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants and young children
Mental health patients

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using 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
Assuming a power of 80% and alpha risk of 0.05 estimation of sample size is based on previous literature with a sample size of 200 deemed sufficient to detect a difference between the two groups.

Continuous variables will be summarised using means and standard deviations, medians and interquartile ranges. A summary of categorical variables will be by frequencies and percentages. Comparisons between the control group and interventional group will be undertaken using student's t-test for normally distributed data and Mann Whitney U test for data not normally distributed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/05/2022
Actual
16/05/2022
Date of last participant enrolment
Anticipated
24/07/2022
Actual
26/07/2022
Date of last data collection
Anticipated
29/07/2022
Actual
2/08/2022
Sample size
Target
200
Accrual to date
Final
174
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 22190 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 37344 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 311217 0
Charities/Societies/Foundations
Name [1] 311217 0
The Western Australian Nurses Memorial Charitable Trust
Country [1] 311217 0
Australia
Primary sponsor type
Individual
Name
Dr Hugh Davies
Address
School of Nursing & Midwifery
Edith Cowan University
270 Joondalup Drive
JOONDALUP 6027
Western Australia
Country
Australia
Secondary sponsor category [1] 312585 0
Individual
Name [1] 312585 0
Professor Elisabeth Jacob
Address [1] 312585 0
Faculty of Health Sciences
Head of School (Victoria)
School of Nursing, Midwifery and Paramedicine
Australian Catholic University
Melbourne Campus (St Patrick's)
The Mary Glowrey Building
115 Victoria Parade
FITZROY 3065
Victoria
Country [1] 312585 0
Australia
Other collaborator category [1] 282246 0
Individual
Name [1] 282246 0
Dr Linda Coventry
Address [1] 282246 0
Senior Research Fellow
School of Nursing & Midwifery
Edith Cowan University
270 Joondalup Drive
JOONDALUP 6027
Western Australia
&
Adjunct Research Fellow with the Centre for Nursing Research
Sir Charles Gairdner Hospita
Hospital Avenue
NEDLANDS 6009
Western Australia
Country [1] 282246 0
Australia
Other collaborator category [2] 282247 0
Individual
Name [2] 282247 0
Alycia Jacob
Address [2] 282247 0
Research Fellow
James Cook University
Murtupuni Campus
MOUNT ISA 4825
Queensland
&
Conjoint Associate Lecturer
School of Medicine
UNSW Sydney
Cnr High St & Botany St
KENSINGTON 2052
New South Wales
Country [2] 282247 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310745 0
Ramsey Health Care WA/SA Human Research Ethics Committee
Ethics committee address [1] 310745 0
Ethics committee country [1] 310745 0
Australia
Date submitted for ethics approval [1] 310745 0
Approval date [1] 310745 0
08/11/2021
Ethics approval number [1] 310745 0
HREC 2144W

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118718 0
Dr Hugh Davies
Address 118718 0
School of Nursing & Midwifery
Edith Cowan University
270 Joondalup Drive
JOONDALUP 6027
Western Australia
Country 118718 0
Australia
Phone 118718 0
+61 08 6304 3511
Fax 118718 0
Email 118718 0
h.davies@ecu.edu.au
Contact person for public queries
Name 118719 0
Hugh Davies
Address 118719 0
School of Nursing & Midwifery
Edith Cowan University
270 Joondalup Drive
JOONDALUP 6027
Western Australia
Country 118719 0
Australia
Phone 118719 0
+61 08 6304 3511
Fax 118719 0
Email 118719 0
h.davies@ecu.edu.au
Contact person for scientific queries
Name 118720 0
Hugh Davies
Address 118720 0
School of Nursing & Midwifery
Edith Cowan University
270 Joondalup Drive
JOONDALUP 6027
Western Australia
Country 118720 0
Australia
Phone 118720 0
+61 08 6304 3511
Fax 118720 0
Email 118720 0
h.davies@ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Cannula dwell time
Occurrence of phlebitis
Cannula-related blood stream infections
Causes of cannula failure
Reasons for cannula removal
When will data be available (start and end dates)?
Data will be available on request for 5 years after publication of results
Available to whom?
Researchers on request
Available for what types of analyses?
Only to achieve research aim
How or where can data be obtained?
Contact with principal investigator:
h.davies@ecu.edu.au


What supporting documents are/will be available?




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.