Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Philip Ind
ORCID ID
Contact details
Respiratory Medicine
Imperial College NHS Trust
Hammersmith House
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)20 8383 3269
p.ind@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
INDP1073
Study information
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
Acronym
Study hypothesis
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
Hammersmith and Queen Charlotte's & Chelsea Research Ethics Committee approved on 04 September 2007, reference number: 07/Q0406/79
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/11/2007
Overall trial end date
31/03/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Any patient accepted for elective CABG surgery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant 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
Recruitment start date
01/11/2007
Recruitment end date
31/03/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Respiratory Medicine
London
W12 0HS
United Kingdom
Sponsor information
Organisation
R&D Hammersmith Hospital (UK)
Sponsor details
R&D office Hammersmith Hospital
Hammersmith House
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)20 8383 4959
rgale@hhnt.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Imperial College Healthcare NHS trust (UK)- internal funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Respironics (now Phillips) (UK)- supplied nasal ventilators (BiPAP), consumables and funded staff training
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23582830
Publication citations
-
Results
Al Jaaly E, Fiorentino F, Reeves BC, Ind PW, Angelini GD, Kemp S, Shiner RJ, Effect of adding postoperative noninvasive ventilation to usual care to prevent pulmonary complications in patients undergoing coronary artery bypass grafting: a randomized controlled trial., J. Thorac. Cardiovasc. Surg., 2013, 146, 4, 912-918, doi: 10.1016/j.jtcvs.2013.03.014.