Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

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

Trial website

Contact information



Primary contact

Dr Philip Ind


Contact details

Respiratory Medicine
Imperial College NHS Trust
Hammersmith House
Du Cane Road
W12 0HS
United Kingdom
+44 (0)20 8383 3269

Additional identifiers

EudraCT number number

Protocol/serial number


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


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Post-operative care of coronary artery bypass graft (CABG) patients


Nasal bilevel positive airway pressure (BiPAP) support added to routine post-operative care compared to routine post-operative care

Intervention type



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


Overall trial end date


Reason abandoned


Participant inclusion criteria

Any patient accepted for elective CABG surgery

Participant type


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Respiratory Medicine
W12 0HS
United Kingdom

Sponsor information


R&D Hammersmith Hospital (UK)

Sponsor details

R&D office Hammersmith Hospital
Hammersmith House
Du Cane Road
W12 0HS
United Kingdom
+44 (0)20 8383 4959

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Imperial College Healthcare NHS trust (UK)- internal funding

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


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:

Publication citations

  1. 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.

Additional files

Editorial Notes