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Trial registered on ANZCTR


Registration number
ACTRN12610000942055
Ethics application status
Approved
Date submitted
19/10/2010
Date registered
4/11/2010
Date last updated
10/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Direct extubation onto high flow nasal prongs post cardiac surgery versus standard treatment in obese patients with a body mass index (BMI) of >/= 30: A randomised controlled trial
Scientific title
Direct extubation onto high flow nasal prongs to prevent atelectasis post cardiac surgery versus standard treatment in patients with a BMI >/= 30: A randomised controlled trial
Secondary ID [1] 252917 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atelectasis 258448 0
Obesity 258579 0
Cardiac surgery 258580 0
Condition category
Condition code
Respiratory 258616 258616 0 0
Other respiratory disorders / diseases
Cardiovascular 258719 258719 0 0
Other cardiovascular diseases
Diet and Nutrition 258720 258720 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High flow nasal prongs, direct extubation post cardiac surgery
When the patient meets the extubation criteria of the unit, the patient will be extubated as per unit protocol. The patient will then receive treatment as per Protocol A (control) or B (treatment).

Protocol B (Treatment)
*Patient extubated directly onto HFNP which are humidified to 37 degrees prior to application
*Starting Flow rate set to 35 litres/min and titrated up to a maximum of 50 litres as determined by patient comfort
*Starting FiO2 prescribed by Intensivist
*Patient to remain on HFNP continuously for 8 hours – breaks allowed for nasal care or mobilization
*Flow rate and FiO2 may be titrated to maintain SpO2 > 95% during the treatment period
*HFNP will be removed at the end of the 8 hour period, or until no longer required as determined by the treating intensivist
*Other treatments (i.e. Drug therapy, physiotherapy, upright positioning, and early mobilisation) will be conducted as per standard unit protocol in consultation with the treating intensivist and cardiac surgeon
Intervention code [1] 257444 0
Prevention
Intervention code [2] 257540 0
Treatment: Devices
Comparator / control treatment
Protocol A (Control)
*Respiratory management as per treating intensivist (Hudson mask or Nasal prongs at low flow rates and FiO2 directed by intensivist) until transfer to the ward
*Other treatments (i.e. Drug therapy, physiotherapy, upright positioning, early mobilisation) will be conducted as per standard unit protocol in consultation with the treating intensivist and cardiac surgeon
Control group
Active

Outcomes
Primary outcome [1] 259581 0
Reduction in atelectasis post cardiac surgery
Timepoint [1] 259581 0
Chest radiography will be performed on Day 1 and 5 post surgery and scored for severity of atelectasis using a validated scoring system (Radiological Atelectasis Score) by a radiologist who is blinded to patient identity and treatment
Secondary outcome [1] 266025 0
Reduction in hypoxaemia (as measured by PaO2/FiO2 ratio)
Timepoint [1] 266025 0
Pao2/Fio2 will be calculated from any arterial blood gases taken as part of clinical care during the first 24hrs from return from surgery
Secondary outcome [2] 266026 0
Improvement in patient dyspnoea score
Timepoint [2] 266026 0
Dyspnoea Visual Analogue Scale - measured at 1, 8 and 12 hours post extubation
Secondary outcome [3] 266199 0
Reduction in Respiratory rate
Timepoint [3] 266199 0
Respiratory rate will be collected hourly from the patient's observation sheet for the first 24 hrs after surgery.

Eligibility
Key inclusion criteria
Male or female >/= 18 years
BMI >/= 30
Post on-cardiopulmonary bypass cardiac surgery
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient refusal
Patients requiring direct extubation onto NIPPV
Pneumothorax
Patients unable to tolerate HFNP
Those requiring tracheostomy
Patients extubated as part of end of life treatment

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be enrolled prior to surgery and randomly allocated direct extubation onto high flow nasal prongs or standard treatment at 30-60 minutes prior to extubation. The randomised groups will be written in numbered ordered opaque envelopes prepared by the statistician. It will not be possible to blind the patient, clinical staff or study staff to the treatment allocation. The statistician and radiologist will be blinded to treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be achieved through a computerised random number generator. A randomised list will be created by the statistician (using Excel). The randomised groups will be written in numbered ordered opaque envelopes prepared by the statistician. Randomisation will occur within 30-60 minutes prior to extubation. At that point the nurse will open the envelope and prepare either the standard equipment or the HFNP.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257991 0
Charities/Societies/Foundations
Name [1] 257991 0
The Prince Charles Hospital Foundation
Address [1] 257991 0
Rode Rd
Chermside QLD 4032
Country [1] 257991 0
Australia
Primary sponsor type
Individual
Name
Amanda Corley
Address
Critical Care Research Group
Level 5 Clinical Sciences Building
Rode Rd
Chermside QLD 4032
Country
Australia
Secondary sponsor category [1] 257187 0
Other Collaborative groups
Name [1] 257187 0
Critical Care Research Group
Address [1] 257187 0
Level 2 Adult Intensive Care
Rode Rd
Chermside QLD 4032
Country [1] 257187 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259985 0
The Prince Charles Hospital Human Research and Ethics Committee
Ethics committee address [1] 259985 0
Rode Rd
Chermside QLD 4032
Ethics committee country [1] 259985 0
Australia
Date submitted for ethics approval [1] 259985 0
Approval date [1] 259985 0
13/08/2010
Ethics approval number [1] 259985 0
HREC/10/QPCH/83

Summary
Brief summary
Open heart surgery is being performed on increasing numbers of obese patients. Almost a third of patients undergoing open heart surgery are classified as obese. It is known that these patients are more prone to post operative complications, particularly lung collapse and that they recover more slowly from these complications. This increase in complications and slower recovery leads to longer intensive care unit and hospital stays. Our previous research has shown that high flow nasal prongs (HFNP) create positive airway pressure and that patients who are obese benefit even more from the positive effects of HFNP. Our study also showed that the patients' oxygen levels improved and their breathing felt more comfortable with the HFNP. Therefore, it is necessary that we further investigate the effects of HFNP on obese patients after cardiac surgery, in an attempt to reduce complications, particularly lung collapse.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31806 0
Address 31806 0
Country 31806 0
Phone 31806 0
Fax 31806 0
Email 31806 0
Contact person for public queries
Name 15053 0
Amanda Corley
Address 15053 0
Critical Care Research Group
Level 5 Clinical Sciences Buidling
Rode Rd
Chermside QLD 4032
Country 15053 0
Australia
Phone 15053 0
+61 7 3139 5772
Fax 15053 0
Email 15053 0
amanda_corley@health.qld.gov.au
Contact person for scientific queries
Name 5981 0
Amanda Corley
Address 5981 0
Critical Care Research Group
Level 5 Clinical Sciences Buidling
Rode Rd
Chermside QLD 4032
Country 5981 0
Australia
Phone 5981 0
+61 7 3139 5772
Fax 5981 0
Email 5981 0
amanda_corley@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary