ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000652178

Ethics application status

Approved

Date submitted

16/04/2019

Date registered

1/05/2019

Date last updated

30/06/2024

Date data sharing statement initially provided

1/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

A study to investigate the utility of Optiflow for Pre oxygenation.

Scientific title

A study to investigate the utility of Optiflow for Pre oxygenation prior to anaesthesia.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1231-9048

Trial acronym

Linked study record

This study is being conducted with the same participants as another study (ACTRN12619000613101). The studies have distinct hypotheses and endpoints and will be conducted in series, with this study to be conducted immediately prior to induction of anaesthesia whereas the other study will be conducted after the induction of anaesthesia.

Health condition

Health condition(s) or problem(s) studied:

Desaturation/oxygenation during anaesthesia

airway management

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients will receive four minutes of 50l/min of Nasal High Flow delivered from a prototype flow source, a humidifier, a water chamber, a breathing tube, and a non sealing nasal interface. The treatment will be administered in an operating room under the direction of an anaesthetist immediately prior to induction of anaesthesia

The case report form will record the duration of the intervention, the flows delivered and any variations to the protocol.

This study is being conducted with the same participants as another study (ACTRN12619000613101). The studies have distinct hypotheses and endpoints and will be conducted in series, with this study to be conducted immediately prior to induction of anaesthesia whereas the other study will be conducted after the induction of anaesthesia.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

None.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

PaO2 at 3 minutes after the start of pre-oxygenation An arterial blood gas sample will be taken from an arterial line and a standard blood gas analyser will be used to determine the PaO2.

Timepoint [1]

3 minutes after the start of pre-oxygenation

Secondary outcome [1]

PaO2 at t=0,1,2,3,4 minutes as measured by arterial blood gas drawn from an arterial line and analysed in a standard blood gas analyser

Timepoint [1]

t=1,2,3,0,4 minutes of preoxygenation

Secondary outcome [2]

Oxygen reserve index at t = 0,1,2,3,4 minutes as measured using an oxygen reserve index device (Masimo).

Timepoint [2]

t = 0,1,2,3,4 minutes of preoxygenation

Secondary outcome [3]

PaO2 at t=0,1,2,3,4 minutes as measured by transcutaneous monitoring (radiometer TCM-5)

Timepoint [3]

t=0,1,2,3,4 minutes of preoxygenation

Secondary outcome [4]

SpO2 as measured continuously by a standard pulse oximeter

Timepoint [4]

t=0,1,2,3,4 minutes

Eligibility

Key inclusion criteria

• 18 years and over and less than 80 years in age
• Capable of informed consent
• Undergoing laryngotrachael surgery under general anaesthetic expected to last at least 15 minutes

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• BMI > 35 kg/m2.
• Patients who are deemed unfit for general anaesthesia and/or THRIVE treatment by the anaesthetist.
• Room-air saturation levels <85%
• requiring preoperative oxygen therapy secondary to chronic lung disease
• Pre-existing hypoxemia
• clinically-defined severe concomitant lower airway pulmonary disease
• Known contraindication to Optiflow™ device
• Patients in whom CPAP is contraindicated (e.g. pneumothorax, bullous lung disease, craniofacial trauma, airway, foreign body, unstable haemodynamics)
• history or symptoms of increased intracranial pressure or reduced intracranial compliance ( e.g. headaches, nausea and vomiting, visual changes, mental changes) .
• skull base defects.
• Patients in whom high FiO2 is contraindicated (e.g. patients being treated with Bleomycin)
• Patients undergoing procedures with electrocautery or laser.
• More than 50% (as judged by the anaesthetist) of the nares occluded by the nasal prongs
• Bleeding in nose or oropharynx
• Patients receiving an induction with volatile anaesthetics
• Patients with delicate skin that could be thermally damaged by the transcutaneous monitor

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

This study is a supplementary study and the power calculation was performed for the main study.
The data will be reported using standard statistical measures (e.g. mean +/- SD)

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

28/10/2020

Actual

28/10/2020

Date of last participant enrolment

Anticipated

31/12/2024

Actual

Date of last data collection

Anticipated

31/12/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

auckland

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Fisher & Paykel Healthcare

Address [1]

15 Maurice Paykel Place East Tamaki Auckland 2013

Country [1]

New Zealand

Primary sponsor type

Commercial sector/Industry

Name

Fisher & Paykel Healthcare

Address

15 Maurice Paykel Place
East Tamaki
Auckland 2013

Country

New Zealand

Secondary sponsor category [1]

University

Name [1]

University of Auckland

Address [1]

Faculty of Medical and Health Sciences The University of Auckland Private Bag 92019 Auckland 1142

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Commitee - Northern B

Ethics committee address [1]

Ministry of Health, 
Level 3,Rangitoto Room, Unisys Building, 
650 Great South Road, Penrose, 
Auckland 1051

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

07/05/2019

Approval date [1]

27/11/2019

Ethics approval number [1]

Summary

Brief summary

This study aims to answer the question: Is nasal high flow (Optiflow) efficacious for pre-oxygenation? Pre oxygenation is carried out before the induction of anaesthesia to fill the patient's lungs with Oxygen to prolong safe apnoea time. Usual practice is to perform preoxygenation with a bag and mask but this technique has some usability and patient comfort issues.  Nasal high flow has been reported to be well tolerated in a number of patient groups and may provide a useful alternative.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Alan Merry

Address

Faculty of Medical and Health Sciences The University of Auckland Private Bag 92019 Auckland 1142

Country

New Zealand

Phone

+64 9 923 5751

Fax

[email protected]

Contact person for public queries

Name

Matthew Payton

Address

Fisher&Paykel Healthcare 15 Maurice Paykel Place Auckland 2013

Country

New Zealand

Phone

+64 95740100

Fax

[email protected]

Contact person for scientific queries

Name

Matthew Payton

Address

Fisher&Paykel Healthcare 15 Maurice Paykel Place Auckland 2013

Country

New Zealand

Phone

+64 95740100

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• 1. Investigators with applicable consents and ethical approvals.
2. Regulatory bodies

Conditions for requesting access:
• -

What individual participant data might be shared?

• Data relating to the primary outcome (PaO2) and selected secondary outcomes (those where the data is in a practical form to share such as PaO2, transcutaneous O2/CO2, SpO2)

What types of analyses could be done with individual participant data?

• Meta analyses or similar reviews
Data verification

When can requests for individual participant data be made (start and end dates)?

From:
From the completion of the trial for a minimum of 5 years and a maximum of 10 years.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Following a written request, if the Principal Investigator and Sponsor both approve, then data would be made available as anonymised electronic records.

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
12093	Study protocol			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically