Condition category
Circulatory System
Date applied
06/04/2011
Date assigned
05/07/2011
Last edited
11/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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
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

  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