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
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
-
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.