Effect of postoperative nasal ventilation in patients undergoing coronary artery bypass grafting (CABG)
ISRCTN | ISRCTN85570732 |
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DOI | https://doi.org/10.1186/ISRCTN85570732 |
Secondary identifying numbers | INDP1073 |
- 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 |
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p.ind@imperial.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Screening |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 |
Secondary outcome measures | 1. Lung function and blood gases-Lung function: 1.1. Pre-op lung function is done within 4 weeks of the operation (bed-side spirometry, and then formal departmental spirometry). In patients with a significant obstructive defect {defined as an FEV1 < 70% or [forced expiratory volume in one second (FEV1)/forced vital capacity (FVC )] of < 70%}, spirometry is then done before and after bronchodilator administration as well as body plethysmography for lung volumes and gas transfer. 1.2. Respiratory muscle strength, measured as mouth pressures [maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)] have been measured on majority of patients. 1.3. Post-operative lung function is measured on day 1, 2 and 3 by bed-side spirometry with documentation of oxygen (O2) saturation and fraction of inspired oxygen (FiO2) given to patient. 1.4. Arterial Blood gases: Are measured preoperatively as a baseline, just before the operation. ABG are measured after the operation at the time of ex-tubation, 1hour later, 12 hours later and 24 hours from the time of ex-tubation. The Fio2 is documented for each measurement 2. Intensive treatment unit (ITU) length of stay 3. Occurrence of complications |
Overall study start date | 01/11/2007 |
Completion date | 31/03/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
W12 0HS
United Kingdom
Sponsor information
Hospital/treatment centre
R&D office Hammersmith Hospital
Hammersmith House
Du Cane Road
London
W12 0HS
England
United Kingdom
Phone | +44 (0)20 8383 4959 |
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rgale@hhnt.nhs.uk | |
https://ror.org/05jg8yp15 |
Funders
Funder type
Industry
No information available
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 01/10/2013 | Yes | No |