Clinical trial NCT03967769: Apneic Oxygénation by Nasal Canula During Infants Airway Management Study
Official title: Apneic Oxygénation by Nasal Canula During Infants Airway Management Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant Apnea
Surgical Procedure, Unspecified
Airway Management
Keywords: Apnoeic oxygenation
Airway management
Oxygen insufflation
Paediatric general anaesthesia
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 72
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time between apnoea and issues
timeFrame: Start at the onset of Apnoea
Secondary outcomes:
measure: Minimal SpO2 during the procedure (%)
timeFrame: Between Onset of apnoea and airway management completed
measure: Time to SpO2 = 90% (in seconds)
timeFrame: During Airway Management, after Apnoea Onset
measure: Numbers of Laryngoscopy attempts (n)
timeFrame: During Airway management
measure: Need to Face Mask Reventilating (Yes/No)
timeFrame: During Airway management
measure: Area under SpO2 curve
timeFrame: During Airway management
measure: Respiratory Events (Incidence and type)
timeFrame: During Airway management
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Adeline Gerst
role: PRINCIPAL_INVESTIGATOR
References: