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Trial registered on ANZCTR


Registration number
ACTRN12610000973011
Ethics application status
Approved
Date submitted
10/11/2010
Date registered
11/11/2010
Date last updated
27/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
High Flow Nasal Oxygen Therapy in Patients after Cardiac Surgery
Scientific title
A randomised controlled trial to determine whether the administration of prophylactic high flow nasal oxygen improves pulmonary function in patients following cardiac surgery
Secondary ID [1] 253065 0
N/A
Universal Trial Number (UTN)
U1111-1117-8340
Trial acronym
The HOT-AS study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary function post cardiac surgery 258631 0
Condition category
Condition code
Respiratory 258772 258772 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing cardiac surgery will be invited pre-operatively to participate in this study. At the time of extubation and discontinuation of mechanical ventilation in the ICU post-operatively, patients in the intervention arm will be randomised to receive oxygen therapy for a period of 24 hours via nasal high flow (Optiflow system, Fisher and Paykel Healthcare, NZ Ltd) at 45 L/min. Fraction of inspired oxygen will be titrated to acheive oxygen saturations of >93%. Study treatment will be discontinued at 1000hours post-operative day 2 and need for ongoing oxygen therapy assessed.
Intervention code [1] 257586 0
Treatment: Devices
Comparator / control treatment
Patients undergoing cardiac surgery will be invited pre-operatively to participate in this study. At the time of extubation and discontinuation of mechanical ventilation in the ICU post-operatively, patients in the control arm will be randomised to receive standard care i.e. oxygen via nasal prongs or a simple face mask. Fraction of inspired oxygen will be titrated to acheive oxygen saturations of >93%. Study treatment will be discontinued at 1000hours post-operative day 2 and need for ongoing oxygen therapy assessed.
Control group
Active

Outcomes
Primary outcome [1] 259636 0
Improvement in oxygen saturation as measured by SpO2/FiO2 ratio
Timepoint [1] 259636 0
Baseline, day 1, day3 and discharge from hospital
Secondary outcome [1] 266292 0
Atelectasis on chest x-ray
Timepoint [1] 266292 0
Day1 and day3 post-operative
Secondary outcome [2] 266293 0
Changes in FVC and FEV1 measurements compared to baseline
Timepoint [2] 266293 0
Day2, Day3 post operative and at discharge from hospital
Secondary outcome [3] 266294 0
Use of adjunctive respiratory support therapies
Timepoint [3] 266294 0
Up to one month post enrolment
Secondary outcome [4] 266295 0
All-cause mortality
Timepoint [4] 266295 0
UP to day 28 post enrolment
Secondary outcome [5] 266296 0
Incidence of respiratory complications as reported in medical records whilst in hospital. Patients will also be contacted by telephone at day 28 pos-enrolment to ascertain whether they have visited their general practitioner with respiratory symptoms
Timepoint [5] 266296 0
Up to day 28 post enrolment
Secondary outcome [6] 266297 0
Patient comfort on either oxygen delivery device as assessed on a visual analogue scale
Timepoint [6] 266297 0
Day 0, day1, day2 post enrolment

Eligibility
Key inclusion criteria
Patients will be screened and are eligible for inclusion in the study if all of the following criteria are met:
: over 18 years of age
: informed consent obtained
: scheduled for cardiac surgery involving full median sternotomy.
: cardiac surgery = CABG; valvular; CABG + valve
: patient not normally on NIV at home
: patient is extubated prior to 1000 hours day after surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if any of the following exist:
: contraindication for NHF use e.g. severe nasal septal defect
: need for timely NIV e.g. CPAP to treat obstructive sleep apnoea
: previous recruitment into this study
: patient is likely to be intubated and mechanically ventilated for >24 hours
following operation
: post-operatively patient is still ventilated at 1000 post-op day 1

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Due to the nature of the therapy it is not possible to blind participants or treating clinicians to allocated therapy. Therefore randomisation in blocks of 12 will be performed using opaque, selaed envelopes sequentially numbered. Patients will be enrolled pre-operatively and baseline measurements performed. At the time that the patient is deemed clinically ready for extubation, they will be screened by research staff or bedside clinician to ensure continued participation. The patient will then have an arterial blood gas drawn. Once this has been taken the randomisation envelope will be opened and allocaiton revealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2011
Actual
15/02/2011
Date of last participant enrolment
Anticipated
Actual
11/04/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 3031 0
New Zealand
State/province [1] 3031 0

Funding & Sponsors
Funding source category [1] 258037 0
Charities/Societies/Foundations
Name [1] 258037 0
Green Lane Research & Education Fund Board
Country [1] 258037 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland City Hospital
Address
Private Bag 92024
Auckland
Country
New Zealand
Secondary sponsor category [1] 257227 0
Commercial sector/Industry
Name [1] 257227 0
Fisher & Paykel Healthcare Limited
Address [1] 257227 0
15 Maurice Paykel Place East Tamaki Auckland 1741
Country [1] 257227 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260033 0
Northern X regional ethics committee
Ethics committee address [1] 260033 0
Private Bag 92-522
Wellesley Street
Auckland
Ethics committee country [1] 260033 0
New Zealand
Date submitted for ethics approval [1] 260033 0
19/11/2010
Approval date [1] 260033 0
Ethics approval number [1] 260033 0

Summary
Brief summary
Following cardiac surgery, patients may experience respiratory problems and reduced lung function. This may cause low oxygen levels and often a longer hospital stay. Reduced lung function may also be resistant to simple techniques traditionally used to improve lung function such as patient positioning and physiotherapy. Ensuring adequate oxygen levels post-operatively is vital but there is little published evidence to guide doctors in the selection and use of different oxygen therapy systems. A high flow nasal high oxygen system (Optiflow by Fisher and Paykel Healthcare Ltd) has been shown to deliver some positive airway pressure and this may help lung function. We now wish to study this to see if this is true. Patients in the study will either receive the nasal high flow oxygen or oxygen delivered by a standard face/nasal mask for 24hours after coming off the breathing machine post-operatively. If this proves to be true, patients may well be discharged earlier from the ICU and from hospital, thereby shortening hospital stay and improving hospital throughput.
Trial website
Trial related presentations / publications
Parke R, McGuinness S, Dixon R, Jull A. Open-label, phase II study of routine high-flow nasal oxygen therapy in cardiac surgical patients. British Journal of Anaesthesia 2013;111:925-31
Public notes

Contacts
Principal investigator
Name 31899 0
Mrs Rachael Parke
Address 31899 0
Cardiothoracic and Vascular ICU, Auckland City Hospital, Private Bag 92024, Auckland, New Zealand
Country 31899 0
New Zealand
Phone 31899 0
+6493074949 ext 24489
Fax 31899 0
Email 31899 0
[email protected]
Contact person for public queries
Name 15146 0
Rachael Parke
Address 15146 0
Cardiothoracic and Vascular Intensive Care Unit
Auckland City Hospital
Private Bag 92024
Auckland
Country 15146 0
New Zealand
Phone 15146 0
+6493074949 ext 24489
Fax 15146 0
+6493074906
Email 15146 0
[email protected]
Contact person for scientific queries
Name 6074 0
Rachael Parke
Address 6074 0
Cardiothoracic and Vascular Intensive Care Unit
Auckland City Hospital
Private Bag 92024
Auckland
Country 6074 0
New Zealand
Phone 6074 0
+6493074949 ext 24489
Fax 6074 0
+6493074949 ext 24489
Email 6074 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCan High-flow Nasal Cannula Reduce the Rate of Endotracheal Intubation in Adult Patients With Acute Respiratory Failure Compared With Conventional Oxygen Therapy and Noninvasive Positive Pressure Ventilation?: A Systematic Review and Meta-analysis.2017https://dx.doi.org/10.1016/j.chest.2017.01.004
N.B. These documents automatically identified may not have been verified by the study sponsor.