Apneic Oxygénation by Nasal Canula During Infants Airway Management Study

Surgical Procedure, Unspecified Clinical Trial

— Oxyeno  

Official title:

Apneic Oxygénation by Nasal Canula During Infants Airway Management Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03967769
• Other study ID #: Oxyneo
• Secondary ID: 2018-004127-36
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: November 4, 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: +33 4 73 754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: November 4, 2020
• Est. primary completion date: August 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Airway Management
• Infant Apnea
• Surgical Procedure, Unspecified

Intervention

Device:
• High Flow nasal Cannula
Apnoeic Oxygenation by High Flow Nasal Cannulae

Locations

Country	Name	City	State
France	CHU	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Numbers of Laryngoscopy attempts (n)	Numbers of Laryngoscopy needed to secure Airways	During Airway management
Secondary	Need to Face Mask Reventilating (Yes/No)	: Incidence of Face Mask Reventilating during Airway management, needed by Sp02 reach under 95%	During Airway management
Secondary	Area under SpO2 curve	AUC of SpO2 recorded every 10 seconds	During Airway management
Secondary	Respiratory Events (Incidence and type)	Incidence of respiratory diseases during Airway management (Bronchospasm, Pneumothorax, Laryngospasm, Laryngeal Oedema)	During Airway management