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GIRAFFE – Gastroscopy – Initial Research compaRing supraglottic Airways versus high-Flow nasal oxygen Feasibility Evaluation for children.

GIRAFFE – Gastroscopy – Initial Research compaRing supraglottic Airways versus high-Flow nasal oxygen Feasibility Evaluation for children

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000471785
Acronym
GIRAFFE Pilot Trial
Enrollment
120
Registered
2022-03-25
Start date
2022-10-19
Completion date
2023-08-29
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 d

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

Sponsors

University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
12 Months to 16 Years
Healthy volunteers
No

Inclusion criteria

Age 12months – 16years (15 years +364 days) Elective upper gastrointestinal endoscopy Clinicians’ approval for inclusion

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026