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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

21/07/2024

Date data sharing statement initially provided

25/03/2022

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]

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

Condition category

Condition code

Anaesthesiology

Anaesthetics

Respiratory

Other respiratory disorders / diseases

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Surgery

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]

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]

The rate of participant recruitment assessed by completion of screening and enrollment log

Timepoint [1]

Screening will occur daily by the research assistant until the recruitment target has been met

Primary outcome [2]

Adherence to the protocol without deviation assessed by completion of case report form completed by the research assistant during the gastroscopy

Timepoint [2]

During the gastroscopy for children enrolled

Secondary outcome [1]

Proceduralist satisfaction: Defined by the ease of insertion of the gastroscope as rated on a Likert scale by the proceduralist.

Timepoint [1]

During the gastroscopy for children enrolled

Secondary outcome [2]

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]

Screening will occur daily by the research assistant until the recruitment target has been met

Secondary outcome [3]

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]

Continuous observation by the research assistant for the duration of the surgical procedure

Secondary outcome [4]

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]

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]

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]

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]

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]

During the gastroscopy for children enrolled and during their PACU stay

Secondary outcome [7]

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]

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?

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]

Queensland Children's Hospital - South Brisbane

Recruitment hospital [2]

Perth Children's Hospital - Nedlands

Recruitment postcode(s) [1]

4101 - South Brisbane

Recruitment postcode(s) [2]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Queensland Children's Hospital

Address [1]

501 Stanley Street
South Brisbane, QLD 4101

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Perth Children's Hospital

Address [2]

15 Hospital Ave
Nedlands, WA 6009

Country [2]

Australia

Primary sponsor type

University

Name

University of Queensland

Address

288 Herston Road
Herston QLD 4006, Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee Centre for Children’s Health Research

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

23/02/2022

Approval date [1]

30/03/2022

Ethics approval number [1]

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

A/Prof Susan Humphreys

Address

Centre for Children's Health Research
Level 7
62 Graham St
South Brisbane
QLD, 4101

Country

Australia

Phone

+617 3069 7480

Fax

susan.humphreys@uq.edu.au

Contact person for public queries

Name

Susan Humphreys

Address

Centre for Children's Health Research
Level 7
62 Graham St
South Brisbane
QLD, 4101

Country

Australia

Phone

+617 3069 7480

Fax

susan.humphreys@uq.edu.au

Contact person for scientific queries

Name

Susan Humphreys

Address

Centre for Children's Health Research
Level 7
62 Graham St
South Brisbane
QLD, 4101

Country

Australia

Phone

+61 7 3069 7480

Fax

susan.humphreys@uq.edu.au

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 susan.humphreys@uq.edu.au

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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