Infant ApneaOxyenoNCT03967769
Apneic Oxygénation by Nasal Canula During Infants Airway Management Study
A study testing High Flow nasal Cannula in people with Infant Apnea and Surgical Procedure, Unspecified, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Infant Apnea, Surgical Procedure, Unspecified, Airway Management
- What is being tested?
- High Flow nasal Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 5 Aug 2019to 4 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Emergency surgery
- Crush Induction needed
- High clinical risk of difficult airway management
- Premature before 1 month of life
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- High Flow nasal Cannula
- Keywords
- Apnoeic oxygenation, Airway management, Oxygen insufflation, Paediatric general anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow nasal CannulaDevice
Apnoeic Oxygenation by High Flow Nasal Cannulae
| Study group | Role | What they receive |
|---|---|---|
| Standard Practice | No intervention | 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 | 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. Receives: Device: High Flow nasal Cannula |
| High Flow Oxygenation | Experimental | 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. Receives: Device: High Flow nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Start at the onset of Apnoea
Secondary outcomes (6)
Minimal SpO2 during the procedure (%)
Minimal SpO2 recorded during the onset of apnoea and airway management completed
Measured: 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%
Measured: During Airway Management, after Apnoea Onset
Numbers of Laryngoscopy attempts (n)
Numbers of Laryngoscopy needed to secure Airways
Measured: During Airway management
Need to Face Mask Reventilating (Yes/No)
: Incidence of Face Mask Reventilating during Airway management, needed by Sp02 reach under 95%
Measured: During Airway management
Area under SpO2 curve
AUC of SpO2 recorded every 10 seconds
Measured: During Airway management
Respiratory Events (Incidence and type)
Incidence of respiratory diseases during Airway management (Bronchospasm, Pneumothorax, Laryngospasm, Laryngeal Oedema)
Measured: During Airway management
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start5 Aug 2019
- Primary completion4 Aug 2020 (estimated)
- Study completion4 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeline Gerst, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967769
- Sponsor's protocol ID
- Oxyneo
- Other IDs
- 2018-004127-36, 2018
- Acronym
- Oxyeno
- Status last verified
- Jun 2020
- First submitted
- 24 May 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apneic Oxygénation by Nasal Canula During Infants Airway Management Study
- ClinicalTrials.gov ID
- NCT03967769
- Acronym / sponsor ID
- Oxyeno / Oxyneo
- Keywords
- Apnoeic oxygenation, Airway management, Oxygen insufflation, Paediatric general anaesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 4 Aug 2020 (estimated)
- Study completion
- 4 Nov 2020 (estimated)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Practice | No intervention | –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 | Device: High Flow nasal CannulaInfants 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. |
| High Flow Oxygenation | Experimental | Device: High Flow nasal CannulaInfants 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. |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Emergency surgery
- Crush Induction needed
- High clinical risk of difficult airway management
- Premature before 1 month of life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flow nasal CannulaApnoeic Oxygenation by High Flow Nasal Cannulae | Device | High Flow Oxygenation, Low Flow oxygenation |
Primary outcome
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)
6 secondary outcomes
Minimal SpO2 during the procedure (%)
Time frame: Between Onset of apnoea and airway management completed
Time to SpO2 = 90% (in seconds)
Time frame: During Airway Management, after Apnoea Onset
Numbers of Laryngoscopy attempts (n)
Time frame: During Airway management
Need to Face Mask Reventilating (Yes/No)
Time frame: During Airway management
Area under SpO2 curve
Time frame: During Airway management
Respiratory Events (Incidence and type)
Time frame: During Airway management
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeline Gerst principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow nasal Cannula in people with Infant Apnea and Surgical Procedure, Unspecified, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33 4 73 754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time between apnoea and issues (time frame: Start at the onset of Apnoea). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.