Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000660684
Ethics application status
Approved
Date submitted
29/05/2023
Date registered
19/06/2023
Date last updated
19/06/2023
Date data sharing statement initially provided
19/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Peripheral intravenous catheters: compliance with the Clinical Care Standard and impact on patient experience
Scientific title
Peripheral intravenous catheters: compliance with the Clinical Care Standard and impact on patient experience
Secondary ID [1] 309861 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain caused by insertion of peripherally intravenous catheters. 330124 0
Pain caused by indwelling peripheral intravenous catheters. 330298 0
Sleep disturbance caused by peripheral intravenous cannulas. 330299 0
Sleep disturbance caused by alarming IV pump. 330300 0
Condition category
Condition code
Public Health 327007 327007 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
- Participants will complete a cross-sectional survey using 10-item questionnaire of patient experience, including measures of sleep quality, pain, discomfort, and sleep disturbance on 5-point Likert scale (5 minutes to complete).
- Researches will then observe for PIVC compliance - location of placement, use of extension tubing, dressing used and condition of dressing (1 minute to complete).
- Patients will be observed and questioned >48 hours post insertion of PIVC
- There will be no further follow-up
Intervention code [1] 326190 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334889 0
Number of times PIVC is not inserted over an area of flexion as determined from direct observation of catheter insertion
Timepoint [1] 334889 0
>48 hours post insertion of PIVC
Primary outcome [2] 335037 0
Number of times Extension tubing is used to minimise movement at the insertion site as determined from direct observation of catheter insertion
Timepoint [2] 335037 0
>48 hours post insertion of PIVC
Primary outcome [3] 335038 0
Number of times the PIVC is secured in a way that minimises movement at the insertion site as determined from direct observation of catheter insertion
Timepoint [3] 335038 0
>48 hours post insertion of PIVC
Secondary outcome [1] 422347 0
Number of times the PIVC is secured with a clean, dry, and semi-permeable dressing as determined from direct observation of catheter insertion (Primary Outcome)
Timepoint [1] 422347 0
>48 hours post insertion of PIVC
Secondary outcome [2] 422785 0
Pain related to PIVC insertion
- 5-point Likert scale enquiring about pain on insertion ranging from no pain to worst pain possible.
Timepoint [2] 422785 0
>48 hours post insertion of PIVC
Secondary outcome [3] 422786 0
Pain related to the PIVC while indwelling
- 5-point Likert scale enquiring about pain whilst PIVC indwelling ranging from no pain to worst pain possible.
Timepoint [3] 422786 0
>48 hours post insertion of PIVC
Secondary outcome [4] 422787 0
Sleep disturbance related to the indwelling PIVC
- 5-point Likert scale enquiring about sleep disturbance due to discomfort from the PIVC during hospital stay ranging from no disturbance to a lot of disturbance.
Timepoint [4] 422787 0
>48 hours post insertion of PIVC
Secondary outcome [5] 422788 0
Sleep disturbance related to the noise of alarming PIVC pumps
- 5-point Likert scale enquiring about sleep disturbance associated with alarming IV pump during hospital stay ranging from no disturbance to a lot of disturbance.
Timepoint [5] 422788 0
>48 hours post insertion of PIVC

Eligibility
Key inclusion criteria
Patients 18 years of age or older.
Patients who have had a PIVC in situ for a minimum of two nights in hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients of the Intensive Care Unit.
Patients under 18 years of age.
Patients with documented cognitive impairment (i.e. scores above 0 on 4AT Assessment for Delirium and Cognitive Impairment located in patient medical record)
Patients that do not speak English.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We assume there will be a correlation between increasing scores for optimally inserted, positioned, and secured cannulas (as per the Australian Commission on Safety and Quality in Health Care 2021 Management of Peripheral Cannulas Clinical Care Standards) on a scale of 0 to 4, and patient self-reported pain and quality of sleep scores on a scale of 0 to 4. A clinically significant difference will be considered to be >1 point on a 5-point Likert Scale. Enrolling 138 patients would allow us to detect a correlation coefficient of greater than or equal to 0.3, at 95% power and a 2-sided significance level of 5%.

We will summarise the participant questionnaire items (pain on insertion, pain with cannula in situ, quality of sleep, sleep disturbance from discomfort, and sleep disturbance from pump noise) overall, and by the researcher questionnaire items (flexion area, extension tubing, secured to minimise movement, and secured with a semi-permeable dressing).

First, we will assess the correlation between increasing scores for optimally inserted, positioned, and secured cannulas on a scale of 0 to 4, and patient self-reported pain and quality of sleep scores on a scale of 0 to 4.

Thereafter we will calculate the mean differences (95%C) adjusted for age, sex, how many cannulas they had during the admission, and the number of days they had the cannula(s) inserted.

We will also do a composite (summed) score and adjust for all the researcher items plus the participant demographics.

As there were no validated patient reported outcome measures (PROMs) that were suitable for this study, we will also assess internal consistency across the questionnaire items (Cronbach’s alpha).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2023
Actual
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
31/01/2024
Actual
Sample size
Target
138
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24803 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 40446 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 313922 0
Hospital
Name [1] 313922 0
St Vincent's Hospital
Country [1] 313922 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
390 Victoria Street
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 315942 0
None
Name [1] 315942 0
Address [1] 315942 0
Country [1] 315942 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313068 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 313068 0
St Vincent’s Hospital Research Office
Translational Research Centre
97-105 Boundary Street
Darlinghurst NSW 2010
Ethics committee country [1] 313068 0
Australia
Date submitted for ethics approval [1] 313068 0
25/01/2023
Approval date [1] 313068 0
01/03/2023
Ethics approval number [1] 313068 0
2023/ETH00066

Summary
Brief summary
This study aims to explore the relationship between adherence to four key components of the PIVC Clinical Care Standard: use of extension tubing, adequate securement, use of a semi-permeable dressing, and avoidance of areas of flexion where possible. It also aims to explore the relationships between these factors and patient-reported sleep quality and sleep disturbance.

We hypothesise that pain and sleep disturbance experienced by patients may be lower and sleep quality higher if compliance with CCS indicators related to PIVC placement and securement is high.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126878 0
Dr Lucy Huggett
Address 126878 0
Anaesthetics Department
St Vincent's Hospital
390 Victoria Street
Darlinghurst, NSW 2010
Country 126878 0
Australia
Phone 126878 0
+61 02 8382 3200
Fax 126878 0
Email 126878 0
lucy.huggett@svha.org.au
Contact person for public queries
Name 126879 0
Dr Lucy Huggett
Address 126879 0
Anaesthetics Department
St Vincent's Hospital
390 Victoria Street
Darlinghurst, NSW 2010
Country 126879 0
Australia
Phone 126879 0
+61 02 83821111
Fax 126879 0
Email 126879 0
lucy.huggett@svha.org.au
Contact person for scientific queries
Name 126880 0
Dr Jennifer Stevens
Address 126880 0
Anaesthetics Department
St Vincent's Hospital
390 Victoria Street
Darlinghurst, NSW 2010
Country 126880 0
Australia
Phone 126880 0
+61 02 83821111
Fax 126880 0
Email 126880 0
jennifer.stevens@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19283Study protocol  lucy.huggett@svha.org.au
19284Informed consent form  lucy.huggett@svha.org.au
19285Ethical approval  lucy.huggett@svha.org.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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