ANZCTR - Registration

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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]

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.

Pain caused by indwelling peripheral intravenous catheters.

Sleep disturbance caused by peripheral intravenous cannulas.

Sleep disturbance caused by alarming IV pump.

Condition category

Condition code

Public Health

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Number of times PIVC is not inserted over an area of flexion as determined from direct observation of catheter insertion

Timepoint [1]

>48 hours post insertion of PIVC

Primary outcome [2]

Number of times Extension tubing is used to minimise movement at the insertion site as determined from direct observation of catheter insertion

Timepoint [2]

>48 hours post insertion of PIVC

Primary outcome [3]

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]

>48 hours post insertion of PIVC

Secondary outcome [1]

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]

>48 hours post insertion of PIVC

Secondary outcome [2]

Pain related to PIVC insertion
- 5-point Likert scale enquiring about pain on insertion ranging from no pain to worst pain possible.

Timepoint [2]

>48 hours post insertion of PIVC

Secondary outcome [3]

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]

>48 hours post insertion of PIVC

Secondary outcome [4]

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]

>48 hours post insertion of PIVC

Secondary outcome [5]

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]

>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]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment postcode(s) [1]

2010 - Darlinghurst

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St Vincent's Hospital

Address [1]

390 Victoria Street
Darlinghurst NSW 2010

Country [1]

Australia

Primary sponsor type

Hospital

Name

St Vincent's Hospital

Address

390 Victoria Street
Darlinghurst NSW 2010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital Human Research Ethics Committee

Ethics committee address [1]

St Vincent’s Hospital Research Office
Translational Research Centre
97-105 Boundary Street 
Darlinghurst NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/01/2023

Approval date [1]

01/03/2023

Ethics approval number [1]

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

Dr Lucy Huggett

Address

Anaesthetics Department
St Vincent's Hospital
390 Victoria Street
Darlinghurst, NSW 2010

Country

Australia

Phone

+61 02 8382 3200

Fax

Email

[email protected]

Contact person for public queries

Name

Lucy Huggett

Address

Anaesthetics Department
St Vincent's Hospital
390 Victoria Street
Darlinghurst, NSW 2010

Country

Australia

Phone

+61 02 83821111

Fax

Email

[email protected]

Contact person for scientific queries

Name

Jennifer Stevens

Address

Anaesthetics Department
St Vincent's Hospital
390 Victoria Street
Darlinghurst, NSW 2010

Country

Australia

Phone

+61 02 83821111

Fax

Email

[email protected]

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.	Type	Citation	Link	Email	Other Details	Attachment
19283	Study protocol			[email protected]
19284	Informed consent form			[email protected]
19285	Ethical approval			[email protected]

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.