NCT05846919

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

April 17, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

15 days

First QC Date

April 17, 2023

Last Update Submit

July 30, 2025

Conditions

Rapid Sequence Induction (RSI)Preoxygenation

Keywords

Rapid sequence induction (RSI)High flow nasal oxygenation (HFNO)High flow nasal cannula (HFNC)preoxygenationchildrenpediatricinfant

Outcome Measures

Primary Outcomes (2)

  • Incidence of desaturation under 90%

    peripheral oxygen saturation measured by saturation probe will be evaluated and the saturation at the moment of first successful intubation attempt (defined by the first capnography tracing), the incidence of saturation declined below 90% will be recorded

    Intraoperatively

  • Incidence of manual ventilation during RSI

    incidence of manual ventilation during preoxygenation due to desaturation will be evaluated

    Intraoperatively

Secondary Outcomes (10)

  • Incidence of desaturation under 80%

    Intraoperatively

  • time to desaturation under 90%

    Intraoperatively

  • time to desaturation under 80%

    Intraoperatively

  • time needed for relaxation

    Intraoperatively

  • time needed for intubation

    Intraoperatively

  • +5 more secondary outcomes

Study Arms (3)

Pediatric patients indicated for RSI and face-mask preoxygenation

ACTIVE COMPARATOR

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

Procedure: face-mask preoxygenation

Pediatric patients indicated for RSI and HFNOC preoxygenation

ACTIVE COMPARATOR

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

Procedure: HFNOC preoxygenation

Pediatric patients indicated for RSI and HFNOC + face-mask preoxygenation

EXPERIMENTAL

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

Procedure: HFNOC + face-mask preoxygenation

Interventions

face-mask preoxygenationPROCEDURE

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

Pediatric patients indicated for RSI and face-mask preoxygenation
HFNOC preoxygenationPROCEDURE

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

Pediatric patients indicated for RSI and HFNOC preoxygenation
HFNOC + face-mask preoxygenationPROCEDURE

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

Pediatric patients indicated for RSI and HFNOC + face-mask preoxygenation

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients indicated for rapid sequence induction
  • informed consent

You may not qualify if:

  • decline to participate
  • rapid sequence induction not required for anesthesia induction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brno University Hospital

Brno, South Moravian, 62500, Czechia

Location

Study Officials

  • Petr Stourac, prof. MD., Ph.D., MBA

    Department of paediatric anaesthesia and intensive care medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant under general anesthesia
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Triple group randomized controlled pilot trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 17, 2023

First Posted

May 6, 2023

Study Start

June 15, 2023

Primary Completion

June 30, 2023

Study Completion

July 1, 2025

Last Updated

August 3, 2025

Record last verified: 2025-07

Locations

CZ(1)