ANZCTR - Registration

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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]

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

Condition category

Condition code

Respiratory

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]

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]

Improvement in oxygen saturation as measured by SpO2/FiO2 ratio

Timepoint [1]

Baseline, day 1, day3 and discharge from hospital

Secondary outcome [1]

Atelectasis on chest x-ray

Timepoint [1]

Day1 and day3 post-operative

Secondary outcome [2]

Changes in FVC and FEV1 measurements compared to baseline

Timepoint [2]

Day2, Day3 post operative and at discharge from hospital

Secondary outcome [3]

Use of adjunctive respiratory support therapies

Timepoint [3]

Up to one month post enrolment

Secondary outcome [4]

All-cause mortality

Timepoint [4]

UP to day 28 post enrolment

Secondary outcome [5]

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]

Up to day 28 post enrolment

Secondary outcome [6]

Patient comfort on either oxygen delivery device as assessed on a visual analogue scale

Timepoint [6]

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?

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Green Lane Research & Education Fund Board

Address [1]

P O Box 110042
Auckland City Hospital
Grafton
Auckland

Country [1]

New Zealand

Primary sponsor type

Hospital

Name

Auckland City Hospital

Address

Private Bag 92024
Auckland

Country

New Zealand

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Fisher & Paykel Healthcare Limited

Address [1]

15 Maurice Paykel Place East Tamaki Auckland 1741

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern X regional ethics committee

Ethics committee address [1]

Private Bag 92-522
Wellesley Street
Auckland

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

19/11/2010

Approval date [1]

Ethics approval number [1]

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

Mrs Rachael Parke

Address

Cardiothoracic and Vascular ICU, Auckland City Hospital, Private Bag 92024, Auckland, New Zealand

Country

New Zealand

Phone

+6493074949 ext 24489

Fax

rparke@adhb.govt.nz

Contact person for public queries

Name

Rachael Parke

Address

Cardiothoracic and Vascular Intensive Care Unit
Auckland City Hospital
Private Bag 92024
Auckland

Country

New Zealand

Phone

+6493074949 ext 24489

Fax

+6493074906

rparke@adhb.govt.nz

Contact person for scientific queries

Name

Rachael Parke

Address

Cardiothoracic and Vascular Intensive Care Unit
Auckland City Hospital
Private Bag 92024
Auckland

Country

New Zealand

Phone

+6493074949 ext 24489

Fax

+6493074949 ext 24489

rparke@adhb.govt.nz

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

Source	Title	Year of Publication	DOI
Embase	Can 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.	2017	https://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.

Trial Review

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Documents added manually

Documents added automatically