Effect of postoperative nasal ventilation in patients undergoing coronary artery bypass grafting (CABG)

ISRCTN	ISRCTN85570732
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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Philip Ind
Scientific

Respiratory Medicine
Imperial College NHS Trust
Hammersmith House
Du Cane Road
London
W12 0HS
United Kingdom

Phone	+44 (0)20 8383 3269
Email	p.ind@imperial.ac.uk

Study information

Study design	Randomised controlled trial
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
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

Respiratory Medicine

London
W12 0HS
United Kingdom

Sponsor information

R&D Hammersmith Hospital (UK)
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
Email	rgale@hhnt.nhs.uk
"ROR"	https://ror.org/05jg8yp15

Funders

Funder type

Industry

Imperial College Healthcare NHS trust (UK)- internal funding

No information available

Respironics (now Phillips) (UK)- supplied nasal ventilators (BiPAP), consumables and funded staff training

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	01/10/2013		Yes	No