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High Flow Oxygen in Preoxygenation During Rapid Sequence Induction in Infants and Small Children

NCT05846919 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-08-03

No results posted yet for this study

Summary

Airway management is crucial part of the anaesthesia. There is always a considerable risk of complications or even failure during the anaesthesia induction and airway management. The risk could be greater considering anaesthesia in children and neonates because of their anatomical and physiological differences. Children and neonates are more susceptible to hypoxia and bradycardia during induction of anaesthesia, this risk is even greater during the rapid sequence induction/intubation (RSI), in which there is an apnoeic pause because of the absence of manual ventilation. Because of the pause it is necessary to provide enough oxygen in advance during preoxygenation. The aim of this trial is to compare providing oxygen by face-mask and by high-flow nasal oxygen cannula. Another outcome is to evalute the safety profile RSI in children and neonates.

Conditions

  • Rapid Sequence Induction (RSI)
  • Preoxygenation

Interventions

PROCEDURE

face-mask preoxygenation

face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes.

PROCEDURE

HFNOC preoxygenation

HFNOC preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes.

PROCEDURE

HFNOC + face-mask preoxygenation

HFNOC (flow 2 L/kg/minute) + face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) - with 100 % oxygen for three minutes.

Sponsors & Collaborators

  • Masaryk University

    collaborator OTHER

  • Brno University Hospital

    lead OTHER

Principal Investigators

  • Petr Stourac, prof. MD., Ph.D., MBA · Department of paediatric anaesthesia and intensive care medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-15
Primary Completion
2023-06-30
Completion
2025-07-01

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05846919 on ClinicalTrials.gov