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

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ClinicalTrials.gov Identifier: NCT03967769
Recruitment Status : Not yet recruiting
First Posted : May 30, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment Phase
Infant Apnea Surgical Procedure, Unspecified Airway Management Device: High Flow nasal Cannula Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

At each participating center, patients will be followed up for primary and secondary endpoints by members of the research staff who will be unaware of the trial group allocation. Information on whether the primary and secondary outcomes occur will be collected and entered into the electronic web-based case report form (eCRF) by trial or clinical trained personal (clinical research associate), blinded to the allocation group, under the supervision of the local principal investigator (PI) or designee who will also be unaware of the trial group allocation.

Finally, the independent trial statistician and the members of the data monitoring and safety committee (DMSC) will also remain blinded for the allocation during analysis.

Primary Purpose: Prevention
Official Title: Apneic Oxygénation by Nasal Canula During Infants Airway Management Study
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Time between apnoea and issues [ Time Frame: Start at the onset of Apnoea ]

    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)


Secondary Outcome Measures :
  1. Minimal SpO2 during the procedure (%) [ Time Frame: Between Onset of apnoea and airway management completed ]
    Minimal SpO2 recorded during the onset of apnoea and airway management completed

  2. Time to SpO2 = 90% (in seconds) [ Time Frame: During Airway Management, after Apnoea Onset ]
    Time between onset of apnoea and SpO2 = 90%, if it occurs, even if mask ventilation is started at Spo2 =95%

  3. Numbers of Laryngoscopy attempts (n) [ Time Frame: During Airway management ]
    Numbers of Laryngoscopy needed to secure Airways

  4. Need to Face Mask Reventilating (Yes/No) [ Time Frame: During Airway management ]
    : Incidence of Face Mask Reventilating during Airway management, needed by Sp02 reach under 95%

  5. Area under SpO2 curve [ Time Frame: During Airway management ]
    AUC of SpO2 recorded every 10 seconds

  6. Respiratory Events (Incidence and type) [ Time Frame: During Airway management ]
    Incidence of respiratory diseases during Airway management (Bronchospasm, Pneumothorax, Laryngospasm, Laryngeal Oedema)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967769


Contacts
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Contact: Lise Laclautre +33 4 73 754963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
CHU Not yet recruiting
Clermont-Ferrand, France
Contact: Adeline Gerst         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Adeline Gerst University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03967769     History of Changes
Other Study ID Numbers: Oxyneo
2018-004127-36 ( EudraCT Number )
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Apnoeic oxygenation
Airway management
Oxygen insufflation
Paediatric general anaesthesia