Airway Interventions During Intravenous Anesthesia in Children Undergoing Direct Laryngoscopy for Surgical Procedures Using High Flow Nasal Versus Low Flow Oxygen. A Pilot Study.(Flowkid)
1 other identifier
interventional
20
1 country
1
Brief Summary
The goal of this clinical trial is to evaluate possible differences in airway responses and interventions during intravenous anesthesia for direct laryngoscopy in children when comparing two oxygenation methods (conventional low flow oxygen supplementation via nasopharyngeal tube versus Nasal High Flow Therapy with the OptiflowTM system ).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2023
CompletedFirst Posted
Study publicly available on registry
September 14, 2023
CompletedStudy Start
First participant enrolled
November 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2025
CompletedJuly 9, 2025
July 1, 2025
1.5 years
September 7, 2023
July 4, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
the incidence of airway interventions
defined as the need to interrupt the procedure in order to maintain adequate oxygenation with mask ventilation, introduction of a nasopharyngeal airway or intubation with endotracheal tube
during surgery
incidence of desaturation
defined as pulse oxygen saturation(SpO2) lower than 90% for more than 30 seconds
during surgery
incidence of bradycardia
defined as a change of 30 percent beyond the baseline of heart rate
during surgery
incidence of tachycardia
defined as a change of 30 percent beyond the baseline of heart rate
during surgery
Secondary Outcomes (1)
Comparison of the oropharyngeal mucosa before and after the procedure
before induction of anesthesia and at end of surgery
Study Arms (2)
low flow oxygen
ACTIVE COMPARATORhigh flow oxygen
ACTIVE COMPARATORInterventions
low flow oxygen with nasopharyngeal tube
high flow oxygen with OptiflowTM Nasal High Flow
Eligibility Criteria
You may qualify if:
- scheduled for elective direct laryngoscopy with surgical intervention
- written informed consent of the parents or legal guardian
You may not qualify if:
- refusal of informed consent
- known allergy for dexmedetomidine
- known allergy for remifentanil
- pulse oxygen saturation (SpO2) is lower than 85%, at induction of anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Antwerp University Hospital
Edegem, Antwerp, 2650, Belgium
Study Officials
- PRINCIPAL INVESTIGATOR
Sophie Aerts, MD
University Hospital, Antwerp
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2023
First Posted
September 14, 2023
Study Start
November 28, 2023
Primary Completion
May 16, 2025
Study Completion
May 16, 2025
Last Updated
July 9, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share