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High-flow Nasal Cannula Oxygenation During Rapid Sequence Induction in Children

NCT05063084 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-05-06

No results posted yet for this study

Summary

This randomised study aims to compare the utilization of high-flow humidified nasal oxygenation (HFNO) with standard care, using apnoeic facemask oxygenation, during rapid sequence induction (RSI) of anesthesia in young children.

170 children aged less then 11 years, admitted to the operating room for surgery and with a medical indication of a RSI of anesthesia will be recruited in one university hospital (Necker-Enfants-Malades in Paris).

Children will be randomly assigned into two groups: the control group will benefit of standard care and the HFNO group will receive heated and humidified oxygen through a nasal cannula device during pre-oxygenation and apnoea time prior to tracheal intubation.

HFNO has been evaluated and showed benefits in rapid sequence induction of anesthesia in adults and prolonged apnea time before desaturation in children. To the investigators' knowledge the potential benefit of HFNO during RSI in young children remain to be evaluated.

Conditions

  • Pediatric Surgery
  • Rapid Sequence Induction

Interventions

PROCEDURE

Optiflow - HFNO

Pre-oxygenation: HFNO with a 2 L/Kg/min flow during 2 min with 100% FiO2 Oxygenation: during the tracheal intubation, HFNO with a 2 L/Kg/min flow during 2 min with 100% FiO2

PROCEDURE

Classic

Pre-oxygenation: with facemask during 2 min with 100% FiO2, flow 6 to 8L/min. No oxygenation during the tracheal intubation

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Gilles ORLIAGUET, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-09
Primary Completion
2024-02-06
Completion
2024-02-06

Countries

  • France

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 NCT05063084 on ClinicalTrials.gov