Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001433493
Ethics application status
Approved
Date submitted
26/09/2016
Date registered
14/10/2016
Date last updated
10/11/2020
Date data sharing statement initially provided
10/11/2020
Date results information initially provided
10/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
THRIVER-F: Feasibility of high-flow transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in children and adults undergoing surgery under general anaesthesia
Scientific title
THRIVE-F: Feasibility of THRIVE for improving the reliability of routine preoxygenation before induction of anaesthesia in children and adults undergoing surgery under general anaesthesia.
Secondary ID [1] 290192 0
Nil
Universal Trial Number (UTN)
Trial acronym
THRIVER-F
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical patients 300341 0
Condition category
Condition code
Anaesthesiology 300201 300201 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fisher & Paykel’s Optiflow Trademark uses modified nasal catheters to deliver humidified warm oxygen to patients at high flow (e.g. 70 l per minute). Humidity makes the treatment tolerable. This device has been used in millions of patients in many countries in various clinical settings, including intensive care units and in pediatrics. The value of transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in supporting oxygenation in the context of certain types of respiratory failure has been demonstrated. It is generally comfortable to use and few risks over conventional methods of non-invasive oxygenation have been described.

Anesthetists or anesthesia technicians will fit the Optiflow Trademark nasal prongs to the patient upon arrival in the operating room (OR) after the acquisition of an initial arterial oxygen saturation (SpO2) reading (or soon thereafter), with flows set to 40 l/min (or as appropriate, 100% oxygen). After induction the flow will be increased to 70 l/min (or as appropriate). THRIVE will be used up until a secure airway has been established to the satisfaction of the anesthetist, after which it will be switched off. If the airway needs to be replaced within 15 minutes, THRIVE will be switched on again for this purpose. We will ask anesthetists to administer 100% oxygen for at least five minutes following intubation (to standardize this across patients for the detection of the fraction end tidal oxygen (FETO2) readings immediately following intubation). At all times anesthetists will be asked to make the safe care of their patients their primary concern, and to modify the use of THRIVE as they see fit to that end. They will be asked to document deviations from the protocol and reasons for the deviation, in the anesthetic record.
Intervention code [1] 295947 0
Treatment: Other
Comparator / control treatment
We will ask participating anesthetists to familiarize themselves with the current Difficult Airway Society (DAS) guidelines and to preoxygenate their patients to these specifications. Specifically, we will ask them to provide preoxygenation with 100% oxygen via a sealing oro-nasal mask and using a standard anesthetic circuit. In this study we will ask them to obtain a FETO2 >87% before starting induction, or to indicate why not if they fail. The inspired fraction of oxygen will be 100% immediately upon securing the endotrachael tube (ETT) for a period of five minutes. Since the patient will have been preoxygenated on the circuit with 100% oxygen the circuit will be “preprimed” with oxygen and ready for immediate use. We will record the first five FETO2 readings following intubation to assess the quality of the preoxygenation.
Control group
Active

Outcomes
Primary outcome [1] 299687 0
Ease of use measured by anesthetists on a visual analogue scale with an optional free comments box.
Timepoint [1] 299687 0
Completed for the peri-induction period, this questionnaire will be filled out by anaesthetists once the peri-induction period is complete and when workload allows
Primary outcome [2] 299688 0
Comfort assessed by patients using a visual analogue scale with an optional free comments box.
Timepoint [2] 299688 0
The participant will complete this prior to induction of anaesthesia.
Secondary outcome [1] 327858 0
FETO2 following intubation of the trachea calculated from the first five readings after intubation. FETO2 will be extracted directly from automated, routine physiological monitoring.
Timepoint [1] 327858 0
First five readings after intubation (times unknown - depends on data collection, usually at 30 second intervals).
Secondary outcome [2] 327859 0
The proportion of patients having an episode of hypoxemia (defined as SpO2 < 90%) of two minutes duration or more during the peri-induction period.
Timepoint [2] 327859 0
For the peri-induction period. The peri-induction period is defined for the purposes of this study as the period from the first recording of oxygen saturation with pulse oximetry until 15 minutes after the first time that an airway is secured with an endotracheal tube to the satisfaction of the anesthetist for a period lasting at least a further 15 minutes.
Secondary outcome [3] 327860 0
The proportion of patients having an episode of severe hypoxemia (defined as SpO2 less than or equal to 85%) of two minutes duration or more during the peri-induction period
Timepoint [3] 327860 0
For the peri-induction period. The peri-induction period is defined for the purposes of this study as the period from the first recording of oxygen saturation with pulse oximetry until 15 minutes after the first time that an airway is secured with an endotracheal tube to the satisfaction of the anesthetist for a period lasting at least a further 15 minutes.
Secondary outcome [4] 327861 0
The proportion of patients for whom FETO2 falls below 87% in the first 5 minutes immediately following intubation. FETO2 will be extracted directly from automated, routine physiological monitoring.
Timepoint [4] 327861 0
The first 5 minutes immediately following intubation

Eligibility
Key inclusion criteria
1. aged 10 years or older
2. having elective surgery under general anesthesia with intravenous induction in the study ORs with a participating anesthetist
3. planned use of an endotracheal tube or a supraglottic airway device.
4. scheduled start of anesthesia during working hours
5. willing to provide informed consent
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known contraindication to Optiflow Trademark device
2. Undergoing an operation on the acute list for which they have not been appropriately fasted
3. More than 50% (as judged by the anesthetist) of the nares occluded by the nasal prongs
4. Bleeding in nose or oropharynx
5. Situations in which continuous positive airway pressure (CPAP) is contraindicated
6. Pre-existing nasal obstruction
7. Pre-existing hypoxemia

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
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
9/01/2017
Actual
17/03/2017
Date of last participant enrolment
Anticipated
30/01/2019
Actual
5/06/2019
Date of last data collection
Anticipated
31/07/2019
Actual
9/09/2019
Sample size
Target
200
Accrual to date
Final
199
Recruitment outside Australia
Country [1] 8250 0
New Zealand
State/province [1] 8250 0

Funding & Sponsors
Funding source category [1] 294552 0
Commercial sector/Industry
Name [1] 294552 0
Fisher & Paykel Healthcare Ltd
Country [1] 294552 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
University of Auckland
Park Road, Grafton
Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 293422 0
Commercial sector/Industry
Name [1] 293422 0
Fisher & Paykel Healthcare Ltd
Address [1] 293422 0
15 Maurice Paykel Pl, Auckland 2013
Country [1] 293422 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295990 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 295990 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 295990 0
New Zealand
Date submitted for ethics approval [1] 295990 0
Approval date [1] 295990 0
14/09/2016
Ethics approval number [1] 295990 0
16/NTB/151

Summary
Brief summary
This is a feasibility study for a larger definitive trial, the ‘THRIVER’ study. The specific objective of the THRIVER study is to answer the following research question: is the routine use of THRIVE for preoxygenation more reliable than current conventional approaches in real world clinical practice?
The purpose of routine pre-oxygenation is to maximize the amount of oxygen stored in the lungs is to provide an increased margin of safety if a ‘can’t intubate can’t oxygenate’ (CICO) situation arises. The conventional approach is to pre-oxygenate the patient to maximize the amount of oxygen stored in the lungs by having them breathe 100% oxygen from the anesthetic circuit using a sealing oro-nasal mask. THRIVE pre-oxygenates the patient and also provides ongoing oxygenation during laryngoscopy up to the time an airway is secured with an endotracheal tube or a laryngeal mask. Therefore, the operational definition of the term ‘preoxygenation’ in this protocol includes all oxygen given until either the airway is secured or a patent airway is lost.
In a CICO situation, the airway is typically lost, so the key issue determining the time to desaturation is the quantity of stored oxygen in the lungs at the moment this happens. CICO situations are potentially lethal, but rare, so showing a reduction in mortality associated with this problem is not feasible in a prospective two-group trial. We therefore plan to address this question in the definitive trial through two indirect indicators of the adequacy of oxygenation during the peri-induction period:

1) The incidence of episodes of desaturation which occur in the peri-induction period*. Adequate oxygen stores in the lung should prevent desaturation from occurring provided adequate cardiac output is maintained, so any episode of desaturation reflects a failure to maintain adequate stores of oxygen at that moment in time (with the same caveat).
2) End tidal oxygen fraction (FETO2) immediately after an airway has been secured with an endotracheal tube or supraglottic airway. During conventional preoxygenation, a FETO2 > 87% is used as an endpoint, but this may drop during laryngoscopy. With THRIVE, FETO2 cannot readily be measured while preoxygenation is occurring. If 100% oxygen is used for the first few minutes after an airway has been secured, FETO2 should provide a good indication of the success or otherwise of preoxygenation up to that point in time – which is what matters clinically.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69170 0
Prof Alan F Merry
Address 69170 0
Faculty Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1010
Country 69170 0
New Zealand
Phone 69170 0
+64 9 923 9300
Fax 69170 0
Email 69170 0
[email protected]
Contact person for public queries
Name 69171 0
Dr Jacqueline Hannam
Address 69171 0
Faculty Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1010
Country 69171 0
New Zealand
Phone 69171 0
+64 9 3737599
Fax 69171 0
Email 69171 0
[email protected]
Contact person for scientific queries
Name 69172 0
Dr Jacqueline Hannam
Address 69172 0
Faculty Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1010
Country 69172 0
New Zealand
Phone 69172 0
+64 9 3737599
Fax 69172 0
Email 69172 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
Dimensions AIEase and comfort of pre-oxygenation with high-flow nasal oxygen cannulae vs. facemask: a randomised controlled trial2022https://doi.org/10.1111/anae.15853
N.B. These documents automatically identified may not have been verified by the study sponsor.