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

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Surgical Procedure, Unspecified; Airway Management; Infant Apnea

Treatments: Device: High Flow nasal Cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT03967769

2018-004127-36 (EudraCT Number)

Oxyneo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: Under 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 3 patient groups

Standard Practice

No Intervention group

Description:

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.

Low Flow oxygenation

Experimental group

Description:

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.

Treatment:

Device: High Flow nasal Cannula

High Flow Oxygenation

Experimental group

Description:

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.

Treatment:

Device: High Flow nasal Cannula