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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Surgery; Rapid Sequence Induction
• Intervention / Treatment: Procedure: Optiflow - HFNO; Procedure: Classic

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nadège SALVI, MD; Phone Number: +33 1 44 49 48 79; Email: nadege.salvi@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Hopital Necker - Enfants malades
    • Contact: Nadège SALVI, MD; Phone Number: +33 1 44 49 48 79; Email: nadege.salvi@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: OHD (HFNO); High flow nasal oxygen	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; Other Names: OHD (Oxygenation Haut Débit)
OTHER: Control; Classic pre-oxygenation with facemask	Procedure: Classic; Pre-oxygenation: with facemask during 2 min with 100% FiO2, flow 6 to 8L/min. No oxygenation during the tracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation level	Measurement of the lowest oxygen saturation during the tracheal intubation process	Up to 10 minutes
Tracheal intubation without facemask reventilation	Tracheal intubation without facemask reventilation	Up to 10 minutes
Number of attempted tracheal intubations required to succeed the process	Number of attempted tracheal intubations required to succeed the process	Up to 10 minutes
Occurrence of all adverse events	Occurrence of all adverse events during tracheal intubation in the operating room (linked or not to the use of HFNO)	until the exit of the recovery room
Satisfaction of the anaesthetist and the anaesthesia team regarding the use of HFNO	Questionnaire about satisfaction, the use of the procedure, stress level and potential genes	Exit of the recovery room

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 9, 2023
• Primary Completion (ANTICIPATED): September 1, 2024
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (ACTUAL): September 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: preoxygenation; pediatric; rapid sequence induction; nasal high flow oxygen
• Other Study ID Numbers: APHP201164; 2021-A01419-32 (OTHER: ID-RCB Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No