ISRCTN ISRCTN85787933
DOI https://doi.org/10.1186/ISRCTN85787933
Secondary identifying numbers HTA 95/16/06
Submission date
25/04/2003
Registration date
25/04/2003
Last edited
08/11/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Angela Boland
Scientific

University of Liverpool
Ashton Street Medical School
Ashton Street
Liverpool
L69 3GE
United Kingdom

Phone +44 (0)151 794 5541
Email a.boland@liv.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleCentral line insertion project (CLIP)
Study acronymCLIP
Study objectivesA 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(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedNot applicable
Intervention1. 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 typeOther
Primary outcome measureCatheter-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 measuresOther outcomes measures included arterial puncture, haematoma, infection, failed insertion and assistance from other healthcare professionals.
Overall study start date01/01/1999
Completion date31/12/2000

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants400
Key inclusion criteriaNot provided at time of registration.
Key exclusion criteriaNot provided at time of registration.
Date of first enrolment01/01/1999
Date of final enrolment31/12/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Liverpool
Liverpool
L69 3GE
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article HTA monograph 01/04/2003 Yes No

Editorial Notes

08/11/2022: Internal review.