Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000356369
Ethics application status
Approved
Date submitted
2/03/2017
Date registered
8/03/2017
Date last updated
9/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of high flow nasal oxygen device for pre-oxygenation in neurosurgical patients: a randomised controlled trial
Scientific title
The use of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for pre-oxygenation in neurosurgical patients: a randomised controlled trial
Secondary ID [1] 291326 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-oxygenation device 302307 0
Condition category
Condition code
Anaesthesiology 301890 301890 0 0
Anaesthetics
Surgery 301926 301926 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group will receive Optiflow Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) as their device for pre-oxygenation. Oxygen will be delivered through two nasal prongs. The procedure will be carried out by the treating anaesthetist.
Pre-oxygenation phase: After the patient is placed at a “sniffing” position with a pillow under the head, pre-oxygenation is commenced with appropriate monitoring, resuscitation equipment and assistance in accordance with the Australian and New Zealand College of the Anaesthetists’ guidelines. Bispectral index (BIS) monitor will also be put on the patient. Oxygen is delivered via THRIVE device, which will be turned on for at least 10 minutes before the start of the operation to ensure the air is humidified sufficiently. Patients will be put on a THRIVE device with oxygen (FiO2 of 1.0) delivering at 30 L/min for 30 seconds and then increased to 50 L/min. The humidity and temperature will follow its default setting which is at 37 degree celsius and 100% humidity. After 5 minutes of pre-oxygenation, anaesthetic induction will then begin. THRIVE device will continue to delivery high flow oxygen at 50L/min throughout pre-oxygenation until successful intubation. There will be no pause until we secure the airway.

Induction phase: Propofol will be administered using target controlled infusion (TCI) technique aiming to maintain BIS between 40-60. Opioids will be given at the discretion of the treating anaesthetist. Nerve stimulator will then be calibrated and train of four count (TOF) will commence every 20 seconds. Rocuronium will be given at 1.0mg/kg. Oxygenation via the THRIVE device is continued after patient loses consciousness. Upper airway patency needs to be maintained to ensure adequate apoeic ventilation. If there is any sign of desaturation (SpO2 < 95%) during apoeic oxygenation, the treating anaesthetist is allowed to manage the airway at his/her own discretion, including conversion to bag and mask ventilation if necessary. Airway maneouvres, such as chin lift and jaw thrust; and airway adjuncts, such as oropharyngeal airway will be used at the discretion of the anaesthetist. Once the TOF = 0, the patient will be intubated. After successful intubation, THRIVE will be discontinued and mechanical ventilation will commence. If an unexpected intubation is encountered, the anaesthetist can convert to facemask ventilation if necessary. After this time, the anaesthetist may modify their anaesthetic technique at their discretion.
Intervention code [1] 297354 0
Treatment: Devices
Comparator / control treatment
Control group will receive oxygen delivered via a facemask connected to standard anaesthetic machine set on manual ventilation mode. The procedure will also be carried out by the treating anaesthetist.
Preparation phase: After the patient is placed at a “sniffing” position with a pillow under the head, pre-oxygenation is commenced with appropriate monitoring, resuscitation equipment and assistance in accordance with the Australian and New Zealand College of the Anaesthetists’ guidelines. Bispectral index (BIS) monitor will also be put on the patient. Oxygen is delivered via facemask connected to a standard anaesthetic machine set on manual ventilation mode. 100% oxygen will be delivered at 10 L/min with the adjustable pressure limiting (APL) valve fully open. After 5 minutes of pre-oxygenation, anaesthetic induction will then begin.

Induction phase: Propofol will be administered using target controlled infusion (TCI) technique aiming to maintain BIS between 40-60. Opioids will be given at the discretion of the treating anaesthetist. Nerve stimulator will then be calibrated and train of four count (TOF) will commence every 20 seconds. Rocuronium will be given at 1.0mg/kg. Bag-mask ventilation (BMV) will commence as soon as patient loses consciousness. Manual ventilation is maintained to keep ETCO2 between 35-40mmHg. Airway maneouvres, such as chin lift and jaw thrust; and airway adjuncts, such as oropharyngeal airway will be used at the discretion of the anaesthetist. Once the TOF = 0, patient will be intubated. After successful intubation, mechanical ventilation is commenced. After this time, the anaesthetist may modify their anaesthetic technique at their discretion.
Control group
Active

Outcomes
Primary outcome [1] 301317 0
PaO2 level measured by arterial blood gas drawn from arterial line
Timepoint [1] 301317 0
After 5 minutes of pre-oxygenation
Secondary outcome [1] 332292 0
PaO2 measured by arterial blood gas drawn from arterial line
Timepoint [1] 332292 0
PaO2 ,will also be measured at baseline, pre-intubation, and post-intubation
Secondary outcome [2] 332377 0
PaCO2 measured by arterial blood gas drawn from arterial line
Timepoint [2] 332377 0
At baseline, 5 min after pre-oxygenation; pre-intubation and post-intubation
Secondary outcome [3] 332378 0
SpO2 as measured by pulse oximeter on finger
Timepoint [3] 332378 0
At baseline, 5 min after pre-oxygenation; pre-intubation and post-intubation
Secondary outcome [4] 332379 0
Number of hypoxic episodes defined as O2 sat below 90% as measured by pulse oximeter on finger during the pre-oxygenation and intubation phases
Timepoint [4] 332379 0
From initiation of pre-oxygenation to successful intubation.
Secondary outcome [5] 332380 0
Anaesthetists satisfaction score measured using a 5-point Likert scale
Timepoint [5] 332380 0
From initiation of pre-oxygenation to successful intubation.
Secondary outcome [6] 332381 0
Patient tolerance to THRIVE device measured by patient grading: comfortable, mild discomfort but tolerable, significant discomfort and intolerable
Timepoint [6] 332381 0
From initiation of pre-oxygenation to successful intubation.
Secondary outcome [7] 332382 0
Failure rate of ventilation. Failure is defined as failure to ventilate via the randomised technique, where alternative mechanism of ventilation is required. This will be recorded by an independent observer.
Timepoint [7] 332382 0
From initiation of pre-oxygenation to successful intubation.
Secondary outcome [8] 332383 0
Time taken for BMV or apoeic ventilation before first intubation attempt. This will be measured as the time from anaesthetic induction until TOF = 0 in seconds. This will be recorded by an independent observer.
Timepoint [8] 332383 0
This will be measured as the time from anaesthetic induction until TOF = 0 in seconds.
Secondary outcome [9] 332384 0
Failure rate of intubation. Failure is defined as failure to intubate with direct or indirect laryngoscopy where alternative method is required. This will be recorded by an independent observer.
Timepoint [9] 332384 0
Throughout the intubation process
Secondary outcome [10] 332385 0
Time taken for successful intubation. This is measured from the first attempt at intubation until successfully securing the airway with ETCO2 display. This will be recorded by an independent observer.
Timepoint [10] 332385 0
This is measured from the first attempt at intubation until successfully securing the airway with ETCO2 display.
Secondary outcome [11] 332386 0
Need to revert back to BMV or apoeic ventilation due to failed intubation attempts. This will be recorded by an independent observer.
Timepoint [11] 332386 0
During the process of intubation.
Secondary outcome [12] 332388 0
Any other complications, such as hypoxia, arrhythmia, myocardial ischaemia, cardiac or respiratory arrest. This will be recorded by an independent observer.
Timepoint [12] 332388 0
From initiation of pre-oxygenation to successful intubation.
Secondary outcome [13] 332514 0
Number of adjuncts used for ventilation. This includes guedel airways or nasopharyngeal airways. An independent observer will be recording the data.
Timepoint [13] 332514 0
From initiation of pre-oxygenation to successful intubation.
Secondary outcome [14] 332515 0
Techniques used to intubate. This includes direct or indirect laryngoscopy. This will be recorded by an independent observer.
Timepoint [14] 332515 0
During the intubation process.

Eligibility
Key inclusion criteria
Adults requiring general anaesthetics and arterial line for neurosurgical procedures.
- Adult patients aged greater than or equal to 18 years
- ASA 1-3
- Able to give informed consent
- Having neurosurgical operation, requiring general anaesthesia for asleep oro-tracheal intubation
- Require arterial line insertion pre-operatively
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Non-English speaking
- Risk of aspiration
- BMI > 35
- Known or anticipated difficult airway
- Patients require awake fibre-optic intubation, gas induction or rapid sequence induction
- Known allergy to propofol or rocuronium
- Raised intracranial pressure (clinically or radiologically)
- Known basal skull fracture
- Active nasal bleed

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using a computer-generated randomisation method
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
Based on previous study, the standard deviation (SD) of PaO2 was 50 mmHg after pre-oxygenation with normal facemask breathing. We assume that PaO2 level will be at least 50 mmHg higher in patients receiving THRIVE than patients receiving mask oxygen for pre-oxygenation. With a SD of 50 mmHg, an alpha error of 0.02 and a power of 0.8, the sample size calculation shows that a minimum sample size of 16 patients is required in each group. We will recruit a total of 50 patients to account for potential drop-outs.

Data will be analysed using Fisher-exact test or chi2 test, depending on the size of data set, for categorical data. Unpaired two-tailed t-test or Mann Whitney U-test will be used to examine parametric data, depending on the normality of the data. A P value < 0.05 is considered statistically significant. Repeated measures analysis of variance will also be used to analyse serial datasets, including the changes in PaO2, PaCO2 and SpO2 with time. Post-hoc testing will be performed with an appropriate correction for multiple comparisons

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/03/2017
Actual
16/03/2017
Date of last participant enrolment
Anticipated
2/06/2017
Actual
6/07/2017
Date of last data collection
Anticipated
2/06/2017
Actual
6/07/2017
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7591 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 15489 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 295789 0
Hospital
Name [1] 295789 0
Department of Anaesthesia and Pain Management, The Royal Melbourne Hospital
Country [1] 295789 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Grattan Street, Parkville, Vic 3050, Australia
Country
Australia
Secondary sponsor category [1] 294648 0
None
Name [1] 294648 0
Address [1] 294648 0
Country [1] 294648 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297086 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 297086 0
Ethics committee country [1] 297086 0
Australia
Date submitted for ethics approval [1] 297086 0
27/09/2016
Approval date [1] 297086 0
12/02/2017
Ethics approval number [1] 297086 0
HREC/16/MH/341

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1546 1546 0 0
/AnzctrAttachments/372468-2016.247 Ethics Approval.pdf (Ethics approval)
Attachments [2] 1548 1548 0 0
/AnzctrAttachments/372468-PICF v2 2016.247 clean.pdf (Participant information/consent)
Attachments [3] 1549 1549 0 0
/AnzctrAttachments/372468-Protocol v2 2016.247 clean.doc (Protocol)

Contacts
Principal investigator
Name 72930 0
Dr Irene Ng
Address 72930 0
Staff Consultant Anaesthetist
Royal Melbourne Hospital
Grattan Street
Parkville, Vic 3050
Country 72930 0
Australia
Phone 72930 0
+61-3-93427540
Fax 72930 0
+61-3-93428623
Email 72930 0
[email protected]
Contact person for public queries
Name 72931 0
Irene Ng
Address 72931 0
Staff Consultant Anaesthetist
Royal Melbourne Hospital
Grattan Street
Parkville, Vic 3050
Country 72931 0
Australia
Phone 72931 0
+61-3-93426540
Fax 72931 0
+61-3-93428623
Email 72931 0
[email protected]
Contact person for scientific queries
Name 72932 0
Irene Ng
Address 72932 0
Staff Consultant Anaesthetist
Royal Melbourne Hospital
Grattan Street
Parkville, Vic 3050
Country 72932 0
Australia
Phone 72932 0
+61-3-93427540
Fax 72932 0
+61-3-93428623
Email 72932 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
EmbaseThe Use of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Pre-Oxygenation in Neurosurgical Patients: A Randomised Controlled Trial.2018https://dx.doi.org/10.1177/0310057X1804600403
N.B. These documents automatically identified may not have been verified by the study sponsor.