A prospective randomised trial to assess the beneficial effect of preoperative hyperoxia therapy on postoperative neuropsychological outcome and inflammatory response after cardiopulmonary bypass
| ISRCTN | ISRCTN16916134 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16916134 |
| Secondary identifying numbers | N0084118514 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 27/10/2010
- 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 of protocol
Not provided at time of registration
Contact information
Mr Joseph Alex
Scientific
Scientific
Cardiothoracic Surgery
Castle Hill Hospital
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Does preoperative hyperoxia therapy reduce the serum levels of S100b protein, InterLeukin-6 (IL6), InterLeukin-8 (IL8), L-selectin, P-selectin, Inter-Cellular Adhesion Molecule 1 (ICAM-1), and improve neurological outcome in patients undergoing cardiopulmonary bypass? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Cardiopulmonary bypass |
| Intervention | Randomised controlled trial comparing: 1. Hyperoxia therapy 2. No therapy Study patients will receive the same intra-operative, postoperative and follow-up care as routine patients and as per unit protocol. A 30-day postoperative neuropsychological assessment will be undertaken. The patient will continue to receive routine postoperative follow-up care as per unit protocol. The patients will undergo three sessions of hyperoxia therapy in the hyperbaric chamber situated at the BUPA Hospital, Anlaby Road, Hull. Each therapy consists of three 20-minute sessions in the hyperbaric chamber breathing 1005 O2 at 2.5 atmospheres interspread with five minutes of air breathing. Blood samples will be taken for estimation of serum IL6, IL8, sE-selection, ICAM-1 and neutrophil CD18. This will be taken immediate pre-operation, at the end of the operation, 12 hours, 24 hours, 48 hours and fifth day post-operation. Blood samples for estimation of S100B will be taken immediate pre-operation, at the end of the operation, two hours and four hours after the operation. A baseline neuropsychological test will be done within 24 h prior to the operation. The first postoperative assessment will be carried out when the performance is more stable, that is, three months postoperatively. To ensure objectivity and reliability of the assessment, the testing of each patient will be undertaken by the same doctor. |
| Intervention type | Other |
| Primary outcome measure | Data collected will be entered into the research department computer and statistical analysis will be done using the Stars Direct Package. Demographics, measures and results of data analysis will be represented as tables, graphs, bar charts and pie charts where applicable. Statistical significance will be set at P-value < 0.05. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 07/10/2002 |
| Completion date | 15/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 50 |
| Key inclusion criteria | A total of 50 patients (25 each group), between 20 and 75 years of age undergoing cardiopulmonary bypass. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 07/10/2002 |
| Date of final enrolment | 15/01/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cardiothoracic Surgery
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom
HU16 5JQ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
The North and South Bank Research and Development Consortium (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 | 01/12/2005 | Yes | No |
