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

NCT05063084 | Completed Phase 3

• 2 other identifiers: APHP2011642021-A01419-32
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

nasal high flow oxygen; rapid sequence induction; preoxygenation; pediatric

Outcome Measures

Primary Outcomes (1)

• Intubation without oxygen desaturation episode

  Intubation without oxygen desaturation episode, defined as pulsed oxymetry \<95% during the rapid sequence induction process of anesthesia in the operating room.

  Up to 10 minutes

Secondary Outcomes (5)

• Oxygen saturation level

  Up to 10 minutes

• Tracheal intubation without facemask reventilation

  Up to 10 minutes

• Number of attempted tracheal intubations required to succeed the process

  Up to 10 minutes

• Occurrence of all adverse events

  until the exit of the recovery room

• Satisfaction of the anaesthetist and the anaesthesia team regarding the use of HFNO

  Exit of the recovery room

Study Arms (2)

OHD (HFNO)

EXPERIMENTAL

High flow nasal oxygen

Procedure: Optiflow - HFNO

Control

OTHER

Classic pre-oxygenation with facemask

Procedure: Classic

Interventions

Optiflow - HFNO PROCEDURE

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

Also known as: OHD (Oxygenation Haut Débit)

OHD (HFNO)

Classic PROCEDURE

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

Control

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• child from birth until 10 years
• patient needing (elective or in emergency) surgery under general anesthesia requiring tracheal intubation and fulfilling all criteria for a rapid sequence induction
• Parents or legal guardians signed the Informed consent form
• Social insurance affiliation

You may not qualify if:

• \- child having one or more contraindication to use high flow nasal oxygenation:
• Nasal obstruction
• Recent trauma of aero-digestives tracts
• Epistaxis
• Known or suspected fracture of the skull base
• Cephalo-spinal fluid leak or all other communication between nasal space and intracranial space
• Tuberculosis or other nasal or lung infection
• Pneumothorax or pneumo-mediastin documented or suspected
• Complete limitation of mouth opening

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker - Enfants malades

Paris, 75015, France

Location

MeSH Terms

Interventions

Congresses as Topic

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Gilles ORLIAGUET, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: September 30, 2021
• Study Start: February 9, 2023
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)