Central line insertion project (CLIP)
| ISRCTN | ISRCTN85787933 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85787933 |
| Protocol serial number | HTA 95/16/06 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
Scientific
University of Liverpool
Ashton Street Medical School
Ashton Street
Liverpool
L69 3GE
United Kingdom
| Phone | +44 (0)151 794 5541 |
|---|---|
| a.boland@liv.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Central line insertion project (CLIP) |
| Study acronym | CLIP |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Other outcomes measures included arterial puncture, haematoma, infection, failed insertion and assistance from other healthcare professionals. |
| Completion date | 31/12/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 400 |
| Key inclusion criteria | Not provided at time of registration. |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 31/12/2000 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Liverpool
Liverpool
L69 3GE
United Kingdom
L69 3GE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not 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.
