Effect of postoperative nasal ventilation in patients undergoing coronary artery bypass grafting (CABG)
| ISRCTN | ISRCTN85570732 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85570732 |
| Protocol serial number | INDP1073 |
| Sponsor | R&D Hammersmith Hospital (UK) |
| Funders | Imperial College Healthcare NHS trust (UK)- internal funding, Respironics (now Phillips) (UK)- supplied nasal ventilators (BiPAP), consumables and funded staff training |
- Submission date
- 06/04/2011
- Registration date
- 05/07/2011
- Last edited
- 11/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Coronary artery bypass graft (CABG) surgery is well known to affect the lungs in a number of ways, mainly as a result of lung basal atelectasis (alveoli collapsing at the bottom of the lung), which is usually seen in the first 48 hours after an operation. Patients can end up staying in hospital longer as a result of this additional problem. We have carried out a study using a non-invasive technique (non-invasive ventilation [NIV] with bilevel positive airway pressure [BiPAP]) in patients undergoing CABG with cardiopulmonary bypass, in order to compare the results of using NIV with BiPAP with using routine standard care.
Who can participate?
Participants were patients referred for "on-pump" first time CABG surgery with mild hypothermia (body temperature between 32 and 35°C).
What does the study involve?
Patients were placed at random into one of two groups: either NIV using BiPAP or routine standard care following the operation. Lung performance was measured by levels of carbon dioxide gas (PCO2) and a test of lung volume (FEV1).
What are the possible benefits and risks of participating?
Participants in the NIV with BiPAP group may have a shorter time in hospital with fewer complications. We do not anticipate additional benefits for the routine care group than normally expected. We do not anticipate any side effects from the NIV with BiPAP treatment.
Where is the study run from?
Hammersmith Hospital (London, UK).
When is study starting and how long is it expected to run for?
The study will run from February 2008 to February 2011.
Who is funding the study?
Imperial College Healthcare NHS trust and Respironics (now Phillips).
Who is the main contact?
Dr Philip Ind
p.ind@imperial.ac.uk
Contact information
Scientific
Respiratory Medicine
Imperial College NHS Trust
Hammersmith House
Du Cane Road
London
W12 0HS
United Kingdom
| Phone | +44 (0)20 8383 3269 |
|---|---|
| p.ind@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect on speed of recovery of postoperative nasal ventilation compared to conventional management in patients undergoing coronary artery bypass grafting (CABG): a randomised controlled trial |
| Study objectives | 1. That following CABG surgery post-operative noninvasive ventilation (NIV) support with bilevel positive airway pressure (BiPAP) in all patients may significantly improve respiratory physiology. 2. That this will reduce complications, intensive care unit (ICU) admissions and duration, and length of hospital admissions when compared to conventional management. |
| Ethics approval(s) | Hammersmith and Queen Charlotte's & Chelsea Research Ethics Committee approved on 04 September 2007, reference number: 07/Q0406/79 |
| Health condition(s) or problem(s) studied | Post-operative care of coronary artery bypass graft (CABG) patients |
| Intervention | Nasal bilevel positive airway pressure (BiPAP) support added to routine post-operative care compared to routine post-operative care |
| Intervention type | Other |
| Primary outcome measure(s) |
Hospital length of stay from day of operation to day of fitness-to-discharge-until day when judged fit-for-discharge on the basis of clinical criteria |
| Key secondary outcome measure(s) |
1. Lung function and blood gases-Lung function: |
| Completion date | 31/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | Any patient accepted for elective CABG surgery |
| Key exclusion criteria | 1. Pre-existing significant renal (creatinine>200 umol/L), hepatic or haematological disease 2. Poor left ventricular function 3. Chronic infection 4. Emergency surgery |
| Date of first enrolment | 01/11/2007 |
| Date of final enrolment | 31/03/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
W12 0HS
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
