Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000471785
Ethics application status
Approved
Date submitted
22/02/2022
Date registered
25/03/2022
Date last updated
16/11/2023
Date data sharing statement initially provided
25/03/2022
Date results information initially provided
16/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
GIRAFFE – Gastroscopy – Initial Research compaRing supraglottic Airways versus high-Flow nasal oxygen Feasibility Evaluation for children.
Scientific title
GIRAFFE – Gastroscopy – Initial Research compaRing supraglottic Airways versus high-Flow nasal oxygen Feasibility Evaluation for children
Secondary ID [1] 306504 0
None
Universal Trial Number (UTN)
U1111-1274-8353
Trial acronym
GIRAFFE Pilot Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxygenation technique during paediatric Gastroscopy 325367 0
Condition category
Condition code
Anaesthesiology 322755 322755 0 0
Anaesthetics
Respiratory 322756 322756 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 322757 322757 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 322758 322758 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: High flow nasal oxygen insufflation during the gastroscopy with an anticipated duration 15-30 minutes

Description: High-Flow Nasal Oxygen Insufflation (HFNOI) is insufflation of heated (37 degrees Celsius) and humidified (100%) oxygen at weight-related flow rates matching peak inspiratory flow thereby allowing a known inspired fraction of inspired oxygen.

HFNOI will be delivered during the gastroscopy via the Optiflow™ device at weight-specific flow rates as per the table below delivering a FiO2 of 1.0.

Weight HFNOI Flow rates
0-12 kg 2L/kg/min
13-15kg 30L/min
15-30 kg 35L/min
30-50 kg 40L/min
>50 kg 50L/min

Jaw thrust will be applied to ensure a patent airway until airway instrumentation begins.
Anaesthesia will be maintained via a Total Intravenous Venous Anaesthesia (TIVA) using a combination of dexmedetomidine, propofol +/- an opioid at the discretion of the attending anaesthetist. Anaesthetists may wish to omit opioids in certain circumstances and this will be at the discretion of the anaesthetist. Anaesthesia infusions will be adjusted to maintain both adequate depth of anaesthesia and spontaneous ventilation during the procedure. TIVA is used because inhalation agents can not be delivered when using HFNOI, TIVA is not the intervention of interest.
The adherence to the intervention will be monitored by the research assistant present in the room collecting data and recorded on a case report form
Intervention code [1] 322932 0
Treatment: Devices
Comparator / control treatment
Laryngeal mask airway (LMA) Technique:

Oxygen administration will be via an LMA at a flow rate of up to 6L/min at the discretion of the attending anaesthetist, with the patient spontaneously ventilated or supported with positive pressure. A Positive end-expiratory pressure (PEEP) of up to 5cmH2O may be applied via the adjustable pressure-limiting valve (APL) in spontaneously ventilated patients. Anaesthesia will be maintained via an inhalational anaesthesia technique. Intravenous agents may be utilised to rapidly increase the depth of anaesthesia if required. Intravenous agents & analgesics administered will be as per the choice of the attending anaesthetist.
The adherence to the LMA technique will be monitored by the research assistant present in the room collecting data and recorded on a case report form
Control group
Active

Outcomes
Primary outcome [1] 330554 0
The rate of participant recruitment assessed by completion of screening and enrollment log
Timepoint [1] 330554 0

Screening will occur daily by the research assistant until the recruitment target has been met
Primary outcome [2] 330555 0
Adherence to the protocol without deviation assessed by completion of case report form completed by the research assistant during the gastroscopy
Timepoint [2] 330555 0
During the gastroscopy for children enrolled
Secondary outcome [1] 406655 0
Proceduralist satisfaction: Defined by the ease of insertion of the gastroscope as rated on a Likert scale by the proceduralist.
Timepoint [1] 406655 0
During the gastroscopy for children enrolled
Secondary outcome [2] 406656 0
Anaesthetist/ Proceduralist refusal to participate in the recruitment of patients that are both eligible and deemed appropriate for consenting captured in the screening log
Timepoint [2] 406656 0
Screening will occur daily by the research assistant until the recruitment target has been met
Secondary outcome [3] 406657 0

The proportion of children requiring interruption of the procedure for adverse events such as hypotension, bradycardia or any other life-threatening event assessed by observation and completion of case report form completed by the research assistant during the gastroscopy. These will be documented as adverse eventes on the CRF and graded using the Common Terminology Criteria for Adverse Events (CTCAE6)
Timepoint [3] 406657 0
Continuous observation by the research assistant for the duration of the surgical procedure
Secondary outcome [4] 406658 0
The proportion of patient-reported sore throat reported in terms of a “yes” or “no” answer. Those that answer yes will be asked to rate their sore throat on a Likert scale of 1-3 (1=mild, 2=moderate, 3= severe -sore throat) when appropriate based on the age of the child.
Timepoint [4] 406658 0
in recovery and prior to discharge from hospital

When appropriate, based on the age of the patient, the patient will be asked regarding the presence or absence of a sore throat at the end of their time in recovery and again prior to hospital discharge in terms of a “yes” or “no” answer. Those that answer yes will be asked to rate their sore throat on a Likert scale of 1-3 (1=mild, 2=moderate, 3= severe -sore throat)
Secondary outcome [5] 406659 0
The proportion of post-operative Nausea and Vomiting (PONV) events note in the medical record during the child's time in recovery and prior to hospital discharge
Timepoint [5] 406659 0
The presence or absence of post-operative Nausea and Vomiting (PONV) will be noted in the recovery area and prior to discharge from the hospital. This will be followed up again on the day after the procedure if the child is discharged from the hospital on the same day as the procedure.
Secondary outcome [6] 406660 0
Composite institutional efficiency comparison and PACU scoring. Operating Room efficiency will be assessed by recording the following times: anaesthesia preparation time (mask induction to scope insertion), procedural time (endoscope insertion to endoscope removal), intra Operative time (OR entry to OR exit), PACU time (PACU arrival to discharge readiness), and total perioperative time (induction to discharge readiness).At the completion of the procedure and following transfer to the PACU, time to University of Michigan Sedation Scale (UMSS score) of 2 and length of stay in post anaesthetic care unit will be recorded
Timepoint [6] 406660 0
During the gastroscopy for children enrolled and during their PACU stay
Secondary outcome [7] 407207 0
The proportion of children requiring interruption of the procedure to rescue the oxygenation by positive pressure assisted ventilation assessed by observation and completion of case report form completed by the research assistant during the gastroscopy
Timepoint [7] 407207 0
Continuous observation by the research assistant for the duration of the surgical procedure

Eligibility
Key inclusion criteria
Age 12months – 16years (15 years +364 days)
Elective upper gastrointestinal endoscopy
Clinicians’ approval for inclusion
Minimum age
12 Months
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe gastro-intestinal reflux with aspiration risk necessitating endotracheal intubation
Oesophageal dilatation procedures
Requirement for preoperative oxygen or ventilatory support
Any clinical condition necessitating endotracheal intubation
NHF contraindication – facial trauma, CSF leak
History of pneumothorax in the preceding 3 months
Emergency procedure out of hours
Clinicians’ refusal to participate

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation via computer will be used to achieve allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be allocated to a treatment arm using a computer based randomisation schedule and an allocation of 1:1 per treatment arm.
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
Statistical methods / analysis
Descriptive statistics will be used to report on the baseline characteristics of the total study cohort and each treatment group, as well as by site. As this is a pragmatic feasibility pilot trial, formal statistical comparisons will not be undertaken. All outcomes will be presented as estimates along with 95% confidence interval (CI); feasibility outcomes will be presented only for the total cohort, while safety and efficacy outcomes will be presented for the total cohort, as well as per treatment group. Analyses will be undertaken using intention-to-treat; however, the number and type of protocol deviations will be reported to assist in the feasibility assessment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2022
Actual
19/10/2022
Date of last participant enrolment
Anticipated
30/09/2023
Actual
29/08/2023
Date of last data collection
Anticipated
30/10/2023
Actual
19/09/2023
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 21799 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 21800 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 36857 0
4101 - South Brisbane
Recruitment postcode(s) [2] 36858 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 310847 0
Hospital
Name [1] 310847 0
Queensland Children's Hospital
Country [1] 310847 0
Australia
Funding source category [2] 310849 0
Hospital
Name [2] 310849 0
Perth Children's Hospital
Country [2] 310849 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
288 Herston Road
Herston QLD 4006, Australia
Country
Australia
Secondary sponsor category [1] 312102 0
None
Name [1] 312102 0
Address [1] 312102 0
Country [1] 312102 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310413 0
Human Research Ethics Committee Centre for Children’s Health Research
Ethics committee address [1] 310413 0
Human Research Ethics Committee
Centre for Children’s Health Research
Queensland Children’s Hospital Precinct
Level 7, 62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 310413 0
Australia
Date submitted for ethics approval [1] 310413 0
23/02/2022
Approval date [1] 310413 0
30/03/2022
Ethics approval number [1] 310413 0
HREC/22/QCH/84426

Summary
Brief summary
Infants and children with a symptom or abnormality involving the upper gastro-intestinal system often require a gastroscopy procedure. During anaesthesia for this procedure both the proceduralist and the anaesthetist share the child’s upper airway for delivery of oxygen and for the placement of a small flexible pipe with a fibre-optic camera (endoscope) to directly view the anatomy within the oesophagus, stomach, and upper small intestine. The choice of airway for this procedure is usually at the discretion of the anaesthetist of which various options are currently available. We aim to compare the newer technique of Nasal High Flow (NHF) with conventional ventilation using a laryngeal mask airway (LMA), through a randomised controlled trial in infants and children during upper gastro-intestinal endoscopy. If we can determine that NHF is not inferior to the use of an LMA, this has the potential to both reduce the number of interruptions, improve the access of the scope, and limit the anaesthetic exposure required to successfully complete these procedures in children.

Trial website
Trial related presentations / publications
Public notes
Infants and children with a symptom or abnormality involving the upper gastro-intestinal system often require a gastroscopy procedure. During anaesthesia for this procedure both the proceduralist and the anaesthetist share the child’s upper airway for delivery of oxygen and for the placement of a small flexible pipe with a fibre-optic camera (endoscope) to directly view the anatomy within the oesophagus, stomach, and upper small intestine.

The choice of airway for this procedure is usually at the discretion of the anaesthetist of which various options are currently available. Upper gastro-intestinal scopes in pediatric patients are frequently performed under variable levels of sedation and most anaesthetists utilise either a soft airway device called a laryngeal mask airway (LMA), or a breathing tube placed in the patient’s windpipe which may get in the way of the scope or dislodge . This may result in interruptions to the procedure requiring correction. This may potentially compromise the safety of the child, prolong the procedure, increase exposure to anaesthetic agents and affect the overall success of the procedure. In adult gastroscopies, simple nasal prongs or high flow nasal prongs are used as alternatives to an airway inserted into the patient’s throat to deliver additional oxygen.

Our research team have recently investigated a newer mode of oxygen delivery called Nasal High Flow (NHF). In NHF, warm and humidified oxygen is delivered to the airway via nasal cannula, at a rate determined by the child’s weight. For example, NHF can be delivered at rates of 2L/kg/min. Therefore, a 10kg infant would receive 20 litres per minute. Matching the flow delivered to the patient’s breathing allows the anaesthetist to deliver oxygen to the child at the required concentration. By not having to place an airway into the patients’ throat or windpipe, the number of interruptions to the procedure as well as the potential obscuring of the proceduralists view may be reduced without compromising the delivery of additional oxygen to the child.

Most children presenting for upper gastro-intestinal investigations and procedures have normal airways. Our recent studies have demonstrated that NHF is an effective alternative technique for oxygen delivery that can be safely used in infants and children with both normal and abnormal airways. To date there have been no large-scale studies evaluating Nasal High Flow in comparison to other oxygenation techniques during upper gastro-intestinal scopes in children. Therefore, we aim to compare the technique of NHF with conventional ventilation using a LMA, through a randomised controlled trial in infants and children during upper gastro-intestinal endoscopy. If we can determine that NHF is not inferior to the use of an LMA, this has the potential to both reduce the number of interruptions, improve the access of the scope, and limit the anaesthetic exposure required to successfully complete these procedures in children.

Contacts
Principal investigator
Name 117574 0
A/Prof Susan Humphreys
Address 117574 0
Centre for Children's Health Research
Level 7
62 Graham St
South Brisbane
QLD, 4101
Country 117574 0
Australia
Phone 117574 0
+617 3069 7480
Fax 117574 0
Email 117574 0
[email protected]
Contact person for public queries
Name 117575 0
A/Prof Susan Humphreys
Address 117575 0
Centre for Children's Health Research
Level 7
62 Graham St
South Brisbane
QLD, 4101
Country 117575 0
Australia
Phone 117575 0
+617 3069 7480
Fax 117575 0
Email 117575 0
[email protected]
Contact person for scientific queries
Name 117576 0
A/Prof Susan Humphreys
Address 117576 0
Centre for Children's Health Research
Level 7
62 Graham St
South Brisbane
QLD, 4101
Country 117576 0
Australia
Phone 117576 0
+61 7 3069 7480
Fax 117576 0
Email 117576 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual consented and enrolled participant data collected during the trial on a case-by-case basis at the discretion of Principal Investigator A/Prof Susan Humphreys and Primary Sponsor
When will data be available (start and end dates)?
3 months following publication and ending 5 years following main results publication
Available to whom?
De-identified data on a case-by-case basis at the discretion of Principal Investigator A/Prof Susan Humphreys and Primary Sponsor of researchers with a sound proposal
Available for what types of analyses?
De-identified data on a case-by-case basis at the discretion of Principal Investigator A/Prof Susan Humphreys and Primary Sponsor of researchers with a sound proposal for post-hoc exploratory analysis.
How or where can data be obtained?
Access subject to approvals by Principal Investigator A/Prof Susan Humphreys [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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