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

Pediatric Surgery Clinical Trial

— OPTINECK  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05063084
• Other study ID #: APHP201164
• Secondary ID: 2021-A01419-32
• Status: Recruiting
• Phase: Phase 3
• Start date: February 9, 2023
• Est. completion date: September 2024

Study information

• Verified date: February 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nadège SALVI, MD
• Phone: +33 1 44 49 48 79
• Email: nadege.salvi[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Surgery
• Rapid Sequence Induction

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Necker - Enfants malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Oxygen saturation level	Measurement of the lowest oxygen saturation during the tracheal intubation process	Up to 10 minutes
Secondary	Tracheal intubation without facemask reventilation	Tracheal intubation without facemask reventilation	Up to 10 minutes
Secondary	Number of attempted tracheal intubations required to succeed the process	Number of attempted tracheal intubations required to succeed the process	Up to 10 minutes
Secondary	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
Secondary	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