Apneic Oxygénation by Nasal Canula During Infants Airway Management Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Apneic Oxygénation by Nasal Canula During Infants Airway Management Study

Conditions
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Infant Apnea, Surgical Procedure, Unspecified, Airway Management

Intervention / Treatment
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* Device: High Flow nasal Cannula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Monocentric prospective, randomized, stratified, parallel-group clinical trial with concealed allocation to 3 groups of Apnoeic Oxygenation during Airway management for general anesthesia in elective surgery. All participants will receive French actual standard of care of surgery and anesthesia.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Practice<br>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<br>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<br>* Apnoeic Oxygenation by High Flow Nasal Cannulae<br>|
| Experimental: High Flow Oxygenation<br>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<br>* Apnoeic Oxygenation by High Flow Nasal Cannulae<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apnoeic oxygenation, Airway management, Oxygen insufflation, Paediatric general anaesthesia