Apneic Oxygénation by Nasal Canula During Infants Airway Management Study (Oxyeno)

This is a randomized clinical trial investigating the utility of apneic oxygenation via high flow nasal cannulae during airway management for infants general anaesthesia. Three groups will be compared, a control group at 0 L/min, a 0,2L/Kg/min and a 1L/Kg/min group. The primary outcome will be the time (in seconds) between onset of apnea and one of theses end-points : desaturation (SPO2 <95%) or Airway management completed.

Study Overview

• Status: Unknown
• Conditions: Airway Management; Surgical Procedure, Unspecified; Infant Apnea
• Intervention / Treatment: Device: High Flow nasal Cannula

Detailed Description

Airway management can be a life saving therapy. One major complication that may occur during airway management is a lack of oxygen in the blood, especially in peadiatric population, due to anatomical and physiological considerations. If severe or prolonged, this lack of oxygen can result in permanent brain damage, damage to other vital organs or even death. Pre-oxygenation prior to induction of anaesthesia is standard practice to prevent desaturation and hypoxemia. Apnoeic oxygenation in adults is effective and prolongs the time to desaturation. Apneic oxygenation is a novel method of delivering oxygen to a patient despite a lack of active respiration (i.e. the patient is not breathing on their own and the investigators are not providing the patient an artificial breath). The simplest and least invasive method to provide apneic oxygenation is the application of oxygen through nasal cannula during airway management. The effectiveness of apnoeic oxygenation in the adult is well document, especially in bariatric population or ICU, however only few study are interesting about pediatric population. Recent studies suggest that high flow is similar to low flow oxygenotherapy. Therefore, the aim of this study was to investigate the effectiveness of apnoeic oxygenation during airway management in infants.

This is a randomized clinical trial investigating the utility of apneic oxygenation via high flow nasal cannula during airway management for infant's general anesthesia. Three groups will be compared, a control group at 0 L/min, a 0,2L/Kg/min and a 1L/Kg/min group. The primary outcome will be the time (in seconds) between onset of apnea and one of these end-points : desaturation (SPO2 <95%) or Airway management completed.

All infants included will receive french actual standard of care concerning general anesthesia and peri-operative medicine.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • CHU
    • Contact: Adeline Gerst

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Infants Between 0 (post-conceptionnal age >41 weeks post Amenorrhea) and 24 months of life
• Scheduled for elective surgery under general anesthesia
• Need of orotracheal Intubation by direct laryngoscopy or Video-laryngoscopy

Exclusion Criteria:

• Emergency surgery
• Crush Induction needed
• High clinical risk of difficult airway management
• Premature before 1 month of life

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Practice; Infants will have high Flow nasal cannulae placed into the nares before induction. They will be removed from the nares at the end of the study when the airway has been secured. There will be no oxygen flowing through the cannulae in this group during the study.
Experimental: Low Flow oxygenation; Infants will have conventional nasal cannulae into the nares prior to induction of anesthesia. They will be removed from the nares at the end of the study when the airway has been secured. There will be 0,2L/kg/min of oxygen flowing through the cannulae in this group during the study.	Device: High Flow nasal Cannula; Apnoeic Oxygenation by High Flow Nasal Cannulae
Experimental: High Flow Oxygenation; Infants will have conventional nasal cannulae into the nares prior to induction of anesthesia. They will be removed from the nares at the end of the study when the airway has been secured. There will be 1L/kg/min of oxygen flowing through the cannulae in this group during the study.	Device: High Flow nasal Cannula; Apnoeic Oxygenation by High Flow Nasal Cannulae

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time between apnoea and issues	Time, in seconds, between the onset of Apnoea (No EtCO2 on the capnogram) and one of these two Issues : SpO2< 95%; Airway Management Completed (Orotracheal intubation completed and 3 similar capnograms on the respirator)	Start at the onset of Apnoea

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal SpO2 during the procedure (%)	Minimal SpO2 recorded during the onset of apnoea and airway management completed	Between Onset of apnoea and airway management completed
Time to SpO2 = 90% (in seconds)	Time between onset of apnoea and SpO2 = 90%, if it occurs, even if mask ventilation is started at Spo2 =95%	During Airway Management, after Apnoea Onset
Numbers of Laryngoscopy attempts (n)	Numbers of Laryngoscopy needed to secure Airways	During Airway management
Need to Face Mask Reventilating (Yes/No)	: Incidence of Face Mask Reventilating during Airway management, needed by Sp02 reach under 95%	During Airway management
Area under SpO2 curve	AUC of SpO2 recorded every 10 seconds	During Airway management
Respiratory Events (Incidence and type)	Incidence of respiratory diseases during Airway management (Bronchospasm, Pneumothorax, Laryngospasm, Laryngeal Oedema)	During Airway management

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Adeline Gerst, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2019
• Primary Completion (Anticipated): August 4, 2020
• Study Completion (Anticipated): November 4, 2020

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Airway management; Apnoeic oxygenation; Oxygen insufflation; Paediatric general anaesthesia
• Other Study ID Numbers: Oxyneo; 2018-004127-36 (EudraCT Number)

Drug and device information, study documents

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