Condition category
Not Applicable
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
27/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Angela Boland

ORCID ID

Contact details

University of Liverpool
Ashton Street Medical School
Ashton Street
Liverpool
L69 3GE
United Kingdom
+44 (0)151 794 5541
a.boland@liv.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 95/16/06

Study information

Scientific title

Acronym

CLIP

Study hypothesis

A single centre randomised trial of central venous catheter insertion by a clinical nurse specialist, under image guidance or on the ward without routine access to image guidance. Approximately 400 patients will be randomised to compare safety, adverse events, efficacy, quality of life and cost. The study will identify the incremental cost effectiveness ratio for nurse insertion and develop and evaluate a training programme to generalise these benefits throughout the NHS. A model will be developed to analyse the long term benefits for patients and the NHS from generalised adoption of the optimal methods of insertion throughout the NHS.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Not applicable

Intervention

1. Central venous catheter insertion by a clinical nurse specialist under image guidance
2. Central venous catheter insertion on the ward without routine access to image guidance

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Catheter-tip misplacement and this was expected to be higher in the blind arm. When comparing the skill level of the trainer and the trainees, pneumothorax was the primary clinical outcome measure.

Secondary outcome measures

Other outcomes measures included arterial puncture, haematoma, infection, failed insertion and assistance from other healthcare professionals.

Overall trial start date

01/01/1999

Overall trial end date

31/12/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/01/1999

Recruitment end date

31/12/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Liverpool
Liverpool
L69 3GE
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2003 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/14611735

Publication citations

  1. HTA monograph

    Boland A, Haycox A, Bagust A, Fitzsimmons L, A randomised controlled trial to evaluate the clinical and cost-effectiveness of Hickman line insertions in adult cancer patients by nurses., Health Technol Assess, 2003, 7, 36, iii, ix-x, 1-99.

Additional files

Editorial Notes