An evaluation of the clinical and cost-effectiveness of pulmonary artery flotation catheters (PAC-Man) in intensive care.
| ISRCTN | ISRCTN04539889 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04539889 |
| Secondary identifying numbers | HTA 97/08/03 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 03/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Kathy Rowan
Scientific
Scientific
Intensive Care National Audit & Research Centre
Tavistock House
Tavistock Square
London
WC1H 9HR
United Kingdom
| Phone | +44 (0)20 7388 2856 |
|---|---|
| kathy@icnarc.org |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | PAC-Man |
| Study hypothesis | The primary hypothesis is: there is no significant difference in hospital mortality or costs of care for those critically ill patients in adult ICUs who receive PAFC and those who do not. The secondary hypotheses are: there is no significant difference in hospital mortality or costs of care for those high risk critically ill patients in adult ICUs who receive PAFC and those who do not - where high risk is defined as patients with a hospital mortality risk of 50% or greater; there is no significant difference in hospital mortality or costs of care, by "skill of use", for those critically ill patients in adult ICUs who receive PAFC and those who do not where "skill of use" will encompass insertion technique, interpretation of data from PAFC and subsequent management decisions. Design (i): Systematic review - the systematic review is to inform important methodological criteria for the final design of the subsequent RCT: 1. Evidence of the clinical and cost-effectiveness of PAFC (to help finalise the design of the RCT) 2 Evidence on the indications for PAFC (to help finalise any exclusion criteria and to help inform the risk stratification criteria for the RCT) 3. Evidence of complications following insertion of PAFC (to help inform the "skill of use" stratification and outcome measurement in RCT) 4. Evidence of interpretation/misinterpretation of data from PAFC (to help inform the "skill of use" stratification or the RCT) 5. Evidence on management decisions arising from interpretation of data from PAFC (to help inform the "skill of use" stratification for the RCT). Design (ii): Randomised controlled trial - The proposed RCT will have one primary and two secondary objectives: 1. To evaluate the clinical and cost-effectiveness of PAFC in intensive care patients, including high risk surgical patients, as currently used in the NHS 2. To evaluate the clinical and cost-effectiveness of PAFC in high risk patients 3. To evaluate the clinical and cost-effectiveness of PAFC "skill of use". Setting: Adult general ICUs in the UK Health Technologies Being Assessed: PAFC, as per objectives. Project Timetable: Months 1-12: Systematic review/preparation for RCT/ethical approval Months 13-24: Recruitment/data validation/follow-up Months 25-36: Follow-up/data analysis/writing up/dissemination Sample Size: The most recent and most generalisable information available for sample size calculation derive from adult, general intensive care unit in Scotland in 1995/6. This indicated that 19% of patients received PAFC and that hospital mortality in this group was 52% as compared with 23% for patients without PAFC. To answer the hypotheses with sufficient power (90% power, p<0.05) and assuming 90% compliance, an estimate of X patients per group is required. Recruitment Rate: It is hoped that most ICUs (n=132) participating in the national, comparative audit of patient outcome, co-ordinated by ICNARC (over 50% in England and Wales), will participate in the RCT. Average annual throughput in an average sized intensive care unit is 300 admissions per year of which 57 (19%) are estimated to receive PAFC, 6954 admissions annually in recruited units to the national audit. Evaluation of risk adjustment: Due to the ethical problems of randomising patients to intensive care or not, the evaluation of the "package" of care is reliant on methods of risk adjustment. Five such methods are employed as part of the Case Mix Programme. The ability of these methods to mirror the results of the proposed RCT will be evaluated. The risk adjustment analysis will be performed by individuals masked to the results of the RCT. Such methodological work will inform us of our ability to risk adjust for hospital mortality following intensive care and establish the contribution that high quality clinical databases might make to health technology assessment. |
| Ethics approval(s) | Not provided at time of registration. |
| Condition | Heart disease |
| Intervention | Patients in adult ICUs who are managed using PAC vs those who are not. |
| Intervention type | Other |
| Primary outcome measure | Hospital mortality, defined as death before discharge from hospital, incorporating death before discharge from ICU. There are no secondary outcome measures unless otherwise indicated by results of the systematic review. Economic Evaluation: The costs of care will be estimated using a top-down method. Cost-effectiveness ratios will be estimated for each outcome. Appropriate incremental cost-effectiveness ratios will also be calculated and sensitivity analysis around the cost and outcome of care will be undertaken. |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 01/01/2000 |
| Overall study end date | 30/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1,041 |
| Participant inclusion criteria | All intensive care admissions, including high risk surgical patients. |
| Participant exclusion criteria | Not provided at time of registration. |
| Recruitment start date | 01/01/2000 |
| Recruitment end date | 30/09/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Intensive Care National Audit & Research Centre
London
WC1H 9HR
United Kingdom
WC1H 9HR
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2005 | Yes | No |
