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Completed

NCT Number: NCT05063084

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

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.

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Key information

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Necker - Enfants malades

Paris, 75015, France

About this study

Hypoxic events during rapid sequence induction (RSI) in children remain more frequent than during standard induction. Although the exact incidence is difficult to appreciate. However the deleterious consequences of hypoxemia during tracheal intubation procedures are well known.

HFNO is an effective technique to supplement oxygen including during apnoea. Studies in children have shown benefits both during breathing and apneic situation.

A monocentric controlled randomized study including children, aged less then 11 years, will be conducted in order to assess the potential benefits of this technique during RSI. The rate of successful tracheal intubation without oxygen desaturation is the primary outcome.

Children will be randomly assigned into two groups:

  • The control group will benefit of standard RSI. Pre-oxygenation will be given through facemask with 100% oxygen during 2 minutes, with a flow of 6 to 8 L.min-1 depending on the age of the child. No oxygen will be delivered during laryngoscopy.
  • The HFNO group will be given 2 L.Kg-1.min-1 of humidified and heated 100% O2 through a nasal cannula during a 2 minutes pre-oxygenation and then throughout laryngoscopy.

Adverse events will be recorded and follow-up continued until discharge from the post anesthesia care unit (PACU).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Other names: OHD (Oxygenation Haut Débit)

Classic

Procedure

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

Primary outcomes

  1. Intubation without oxygen desaturation episode

    Time frame: Up to 10 minutes

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

Secondary outcomes

  1. Oxygen saturation level

    Time frame: Up to 10 minutes

    Measurement of the lowest oxygen saturation during the tracheal intubation process

  2. Tracheal intubation without facemask reventilation

    Time frame: Up to 10 minutes

    Tracheal intubation without facemask reventilation

  3. Number of attempted tracheal intubations required to succeed the process

    Time frame: Up to 10 minutes

    Number of attempted tracheal intubations required to succeed the process

  4. Occurrence of all adverse events

    Time frame: until the exit of the recovery room

    Occurrence of all adverse events during tracheal intubation in the operating room (linked or not to the use of HFNO)

  5. Satisfaction of the anaesthetist and the anaesthesia team regarding the use of HFNO

    Time frame: Exit of the recovery room

    Questionnaire about satisfaction, the use of the procedure, stress level and potential genes

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

A Randomised Controlled Trial Comparing Pre-oxygenation Strategies With High-flow Humidified Nasal Oxygenation Versus Apnoeic Facemask Oxygenation During Rapid Sequence Induction in Children Aged Less Then 11 Years

Acronym: OPTINECK

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 30, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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