Pediatric SurgeryPhase 3OPTINECKNCT05063084
High-flow Nasal Cannula Oxygenation During Rapid Sequence Induction in Children
A Phase 3 study testing Optiflow - HFNO and Classic in people with Pediatric Surgery and Rapid Sequence Induction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This randomised study aims to compare the utilization of high-flow humidified nasal oxygenation (HFNO) with standard care, using apnoeic facemask oxygenation, during rapid sequence induction (RSI) of anesthesia in young children. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Pediatric Surgery, Rapid Sequence Induction
- What is being tested?
- Optiflow - HFNO and Classic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2023to 6 Feb 2024
- Phase
- Phase 3
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child from birth until 10 years
- patient needing (elective or in emergency) surgery under general anesthesia requiring tracheal intubation and fulfilling all criteria for a rapid sequence induction
- Parents or legal guardians signed the Informed consent form
- Social insurance affiliation
Who cannot join
- child having one or more contraindication to use high flow nasal oxygenation:
- Nasal obstruction
- Recent trauma of aero-digestives tracts
- Epistaxis
- Known or suspected fracture of the skull base
- Cephalo-spinal fluid leak or all other communication between nasal space and intracranial space
Show all 9Show fewer
- Tuberculosis or other nasal or lung infection
- Pneumothorax or pneumo-mediastin documented or suspected
- Complete limitation of mouth opening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial Comparing Pre-oxygenation Strategies With High-flow Humidified Nasal Oxygenation Versus Apnoeic Facemask Oxygenation During Rapid Sequence Induction in Children Aged Less Then 11 Years
This randomised study aims to compare the utilization of high-flow humidified nasal oxygenation (HFNO) with standard care, using apnoeic facemask oxygenation, during rapid sequence induction (RSI) of anesthesia in young children.
170 children aged less then 11 years, admitted to the operating room for surgery and with a medical indication of a RSI of anesthesia will be recruited in one university hospital (Necker-Enfants-Malades in Paris).
Read more
Children will be randomly assigned into two groups: the control group will benefit of standard care and the HFNO group will receive heated and humidified oxygen through a nasal cannula device during pre-oxygenation and apnoea time prior to tracheal intubation.
HFNO has been evaluated and showed benefits in rapid sequence induction of anesthesia in adults and prolonged apnea time before desaturation in children. To the investigators' knowledge the potential benefit of HFNO during RSI in young children remain to be evaluated.
Read the detailed description
Hypoxic events during rapid sequence induction (RSI) in children remain more frequent than during standard induction. Although the exact incidence is difficult to appreciate. However the deleterious consequences of hypoxemia during tracheal intubation procedures are well known.
HFNO is an effective technique to supplement oxygen including during apnoea. Studies in children have shown benefits both during breathing and apneic situation.
A monocentric controlled randomized study including children, aged less then 11 years, will be conducted in order to assess the potential benefits of this technique during RSI. The rate of successful tracheal intubation without oxygen desaturation is the primary outcome.
Children will be randomly assigned into two groups:
- The control group will benefit of standard RSI. Pre-oxygenation will be given through facemask with 100% oxygen during 2 minutes, with a flow of 6 to 8 L.min-1 depending on the age of the child. No oxygen will be delivered during laryngoscopy.
- The HFNO group will be given 2 L.Kg-1.min-1 of humidified and heated 100% O2 through a nasal cannula during a 2 minutes pre-oxygenation and then throughout laryngoscopy.
Adverse events will be recorded and follow-up continued until discharge from the post anesthesia care unit (PACU).
- Conditions
- Pediatric Surgery, Rapid Sequence Induction
- Being tested
- Optiflow - HFNO, Classic
- Keywords
- nasal high flow oxygen, rapid sequence induction, preoxygenation, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optiflow - HFNOProcedure or surgery
Also called OHD (Oxygenation Haut Débit)
Pre-oxygenation: HFNO with a 2 L/Kg/min flow during 2 min with 100% FiO2 Oxygenation: during the tracheal intubation, HFNO with a 2 L/Kg/min flow during 2 min with 100% FiO2
ClassicProcedure or surgery
Pre-oxygenation: with facemask during 2 min with 100% FiO2, flow 6 to 8L/min. No oxygenation during the tracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| OHD (HFNO) | Experimental | High flow nasal oxygen Receives: Procedure: Optiflow - HFNO |
| Control | Other | Classic pre-oxygenation with facemask Receives: Procedure: Classic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation without oxygen desaturation episode
Intubation without oxygen desaturation episode, defined as pulsed oxymetry <95% during the rapid sequence induction process of anesthesia in the operating room.
Measured: Up to 10 minutes
Secondary outcomes (5)
Oxygen saturation level
Measurement of the lowest oxygen saturation during the tracheal intubation process
Measured: Up to 10 minutes
Tracheal intubation without facemask reventilation
Tracheal intubation without facemask reventilation
Measured: Up to 10 minutes
Number of attempted tracheal intubations required to succeed the process
Number of attempted tracheal intubations required to succeed the process
Measured: Up to 10 minutes
Occurrence of all adverse events
Occurrence of all adverse events during tracheal intubation in the operating room (linked or not to the use of HFNO)
Measured: until the exit of the recovery room
Satisfaction of the anaesthetist and the anaesthesia team regarding the use of HFNO
Questionnaire about satisfaction, the use of the procedure, stress level and potential genes
Measured: Exit of the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start9 Feb 2023
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Gilles ORLIAGUET, MD, PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063084
- Sponsor's protocol ID
- APHP201164
- Other IDs
- 2021-A01419-32
- Acronym
- OPTINECK
- Status last verified
- Apr 2026
- First submitted
- 4 Aug 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing Pre-oxygenation Strategies With High-flow Humidified Nasal Oxygenation Versus Apnoeic Facemask Oxygenation During Rapid Sequence Induction in Children Aged Less Then 11 Years
- ClinicalTrials.gov ID
- NCT05063084
- Acronym / sponsor ID
- OPTINECK / APHP201164
- Conditions
- Pediatric Surgery, Rapid Sequence Induction
- Keywords
- nasal high flow oxygen, rapid sequence induction, preoxygenation, pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 30 Sep 2021 (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 randomised study aims to compare the utilization of high-flow humidified nasal oxygenation (HFNO) with standard care, using apnoeic facemask oxygenation, during rapid sequence induction (RSI) of anesthesia in young children.
170 children aged less then 11 years, admitted to the operating room for surgery and with a medical indication of a RSI of anesthesia will be recruited in one university hospital (Necker-Enfants-Malades in Paris).
Children will be randomly assigned into two groups: the control group will benefit of standard care and the HFNO group will receive heated and humidified oxygen through a nasal cannula device during pre-oxygenation and apnoea time prior to tracheal intubation.
HFNO has been evaluated and showed benefits in rapid sequence induction of anesthesia in adults and prolonged apnea time before desaturation in children. To the investigators' knowledge the potential benefit of HFNO during RSI in young children remain to be evaluated.
Detailed description
Hypoxic events during rapid sequence induction (RSI) in children remain more frequent than during standard induction. Although the exact incidence is difficult to appreciate. However the deleterious consequences of hypoxemia during tracheal intubation procedures are well known.
HFNO is an effective technique to supplement oxygen including during apnoea. Studies in children have shown benefits both during breathing and apneic situation.
A monocentric controlled randomized study including children, aged less then 11 years, will be conducted in order to assess the potential benefits of this technique during RSI. The rate of successful tracheal intubation without oxygen desaturation is the primary outcome.
Children will be randomly assigned into two groups:
- The control group will benefit of standard RSI. Pre-oxygenation will be given through facemask with 100% oxygen during 2 minutes, with a flow of 6 to 8 L.min-1 depending on the age of the child. No oxygen will be delivered during laryngoscopy.
- The HFNO group will be given 2 L.Kg-1.min-1 of humidified and heated 100% O2 through a nasal cannula during a 2 minutes pre-oxygenation and then throughout laryngoscopy.
Adverse events will be recorded and follow-up continued until discharge from the post anesthesia care unit (PACU).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OHD (HFNO) | Experimental | Procedure: Optiflow - HFNOHigh flow nasal oxygen |
| Control | Other | Procedure: ClassicClassic pre-oxygenation with facemask |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- child from birth until 10 years
- patient needing (elective or in emergency) surgery under general anesthesia requiring tracheal intubation and fulfilling all criteria for a rapid sequence induction
- Parents or legal guardians signed the Informed consent form
- Social insurance affiliation
Key exclusion criteria (9 listed)
- child having one or more contraindication to use high flow nasal oxygenation:
- Nasal obstruction
- Recent trauma of aero-digestives tracts
- Epistaxis
- Known or suspected fracture of the skull base
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 |
|---|---|---|
| Optiflow - HFNOAlso: OHD (Oxygenation Haut Débit)Pre-oxygenation: HFNO with a 2 L/Kg/min flow during 2 min with 100% FiO2 Oxygenation: during the tracheal intubation, HFNO with a 2 L/Kg/min flow during 2 min with 100% FiO2 | Procedure or surgery | OHD (HFNO) |
| ClassicPre-oxygenation: with facemask during 2 min with 100% FiO2, flow 6 to 8L/min. No oxygenation during the tracheal intubation | Procedure or surgery | Control |
Primary outcome
Intubation without oxygen desaturation episode
Time frame: Up to 10 minutes
Intubation without oxygen desaturation episode, defined as pulsed oxymetry <95% during the rapid sequence induction process of anesthesia in the operating room.
5 secondary outcomes
Oxygen saturation level
Time frame: Up to 10 minutes
Tracheal intubation without facemask reventilation
Time frame: Up to 10 minutes
Number of attempted tracheal intubations required to succeed the process
Time frame: Up to 10 minutes
Occurrence of all adverse events
Time frame: until the exit of the recovery room
Satisfaction of the anaesthetist and the anaesthesia team regarding the use of HFNO
Time frame: Exit of the recovery room
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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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.
Gilles ORLIAGUET, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Optiflow - HFNO and Classic in people with Pediatric Surgery and Rapid Sequence Induction, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 6 May 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation without oxygen desaturation episode (time frame: Up to 10 minutes). 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 6 May 2026.