Rapid Sequence Induction (RSI)PRSIHFONCT05846919
High Flow Oxygen in Preoxygenation During Rapid Sequence Induction in Infants and Small Children
A study testing face-mask preoxygenation, HFNOC preoxygenation and HFNOC + face-mask preoxygenation in people with Rapid Sequence Induction (RSI) and Preoxygenation, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Airway management is crucial part of the anaesthesia. There is always a considerable risk of complications or even failure during the anaesthesia induction and airway management. The risk could be greater considering anaesthesia in children and neonates because of their anatomical and physiological differences. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Rapid Sequence Induction (RSI), Preoxygenation
- What is being tested?
- face-mask preoxygenation, HFNOC preoxygenation and HFNOC + face-mask preoxygenation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Jun 2023to 1 Jul 2025
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients indicated for rapid sequence induction
- informed consent
Who cannot join
- decline to participate
- rapid sequence induction not required for anesthesia induction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Flow Oxygen in Preoxygenation During Rapid Sequence Induction in Infants and Small Children: Pilot Randomized Controlled Trial
Airway management is crucial part of the anaesthesia. There is always a considerable risk of complications or even failure during the anaesthesia induction and airway management. The risk could be greater considering anaesthesia in children and neonates because of their anatomical and physiological differences. Children and neonates are more susceptible to hypoxia and bradycardia during induction of anaesthesia, this risk is even greater during the rapid sequence induction/intubation (RSI), in which there is an apnoeic pause because of the absence of manual ventilation. Because of the pause it is necessary to provide enough oxygen in advance during preoxygenation. The aim of this trial is to compare providing oxygen by face-mask and by high-flow nasal oxygen cannula. Another outcome is to evalute the safety profile RSI in children and neonates.
Read the detailed description
All patients requiring an acute surgery and rapid sequence induction/intubation will be checked for eligibility criteria and then an informed consent will be obtained. Afterwards, randomization will take place, which will divide a patient into one of three groups: 1) RSI + face-mask preoxygenation, 2) RSI + high-flow nasal oxygen cannula (HFNOC) preoxygenation and 3) RSI + face-mask and HFNOC preoxygenation.
The demographic data, type of surgery and vital signs will be observed. Primary outcomes will be the impact of HFNOC preoxygenation on oxygen saturation by pulse oximetry (SpO2) and heart rate during the induction of anaesthesia. Secondary outcomes will be safety of the RSI protocol, Cormack-Lehane score, incidence of difficult airway management, number of the intubation attempts and episodes of regurgitation/aspiration.
RSI will be done according to our protocol. Initially, equipment will be checked and an i.v. line will be checked/started and then a bolus of ketamine will be given (0,2-0,5 mg/kg intravenously,) for the face-mask/HFNOC tolerance and the table will be tilted to anti-Trendelenburg position. In case of difficult or unable of intravenous line insertion, intramuscular bolus of ketamin (1-3mg/kg i.m.) could be used prior to another attempt. Afterward, the preoxygenation will start according to the randomization result - group 1) face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute), group 2) HFNOC preoxygenation (flow 2 L/kg/minute, max 6 L/minute) and group 3) HFNOC (flow 2 L/kg/minute) + face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) - with 100 % oxygen for three minutes. Then a bolus of anaesthetic and myorelaxant agent will be given (propofol 2,5 mg/kg in haemodynamically stable, ketamine in haemodynamically unstable and rocuronium 1 mg/kg or suxamethonium 1,5 mg/kg if sugammadex bolus was given in last 24 hours). The neuromuscular blockade will be monitored, first intubation attempt will start as soon as single twitch will be bellow 10 % or train-of-four (TOF) bellow 1 or after 60 seconds, whichever comes first. After that, the first intubation attempt will take place, a video laryngoscopy will be used and Cormack-Lehane score will be documented photographically. The attempt will end either by successful intubation with monitored capnography wave or by failure.
- Conditions
- Rapid Sequence Induction (RSI), Preoxygenation
- Being tested
- face-mask preoxygenation, HFNOC preoxygenation, HFNOC + face-mask preoxygenation
- Keywords
- Rapid sequence induction (RSI), High flow nasal oxygenation (HFNO), High flow nasal cannula (HFNC), preoxygenation, children, pediatric, infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
face-mask preoxygenationProcedure or surgery
face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes.
HFNOC preoxygenationProcedure or surgery
HFNOC preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes.
HFNOC + face-mask preoxygenationProcedure or surgery
HFNOC (flow 2 L/kg/minute) + face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) - with 100 % oxygen for three minutes.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients indicated for RSI and face-mask preoxygenation | Active comparator | face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes. Receives: Procedure: face-mask preoxygenation |
| Pediatric patients indicated for RSI and HFNOC preoxygenation | Active comparator | HFNOC preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes. Receives: Procedure: HFNOC preoxygenation |
| Pediatric patients indicated for RSI and HFNOC + face-mask preoxygenation | Experimental | HFNOC (flow 2 L/kg/minute) + face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) - with 100 % oxygen for three minutes. Receives: Procedure: HFNOC + face-mask preoxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of desaturation under 90%
peripheral oxygen saturation measured by saturation probe will be evaluated and the saturation at the moment of first successful intubation attempt (defined by the first capnography tracing), the incidence of saturation declined below 90% will be recorded
Measured: Intraoperatively
Incidence of manual ventilation during RSI
incidence of manual ventilation during preoxygenation due to desaturation will be evaluated
Measured: Intraoperatively
Secondary outcomes (10)
Incidence of desaturation under 80%
peripheral oxygen saturation measured by saturation probe will be evaluated and the saturation at the moment of first successful intubation attempt (defined by the first capnography tracing), the incidence of saturation declined below 90% will be recorded
Measured: Intraoperatively
time to desaturation under 90%
peripheral oxygen saturation measured by saturation probe will be evaluated and the saturation at the moment of first successful intubation attempt (defined by the first capnography tracing), the time to reach saturation below 90% will be recorded
Measured: Intraoperatively
time to desaturation under 80%
peripheral oxygen saturation measured by saturation probe will be evaluated and the saturation at the moment of first successful intubation attempt (defined by the first capnography tracing), the time to reach saturation below 80% will be recorded
Measured: Intraoperatively
time needed for relaxation
time between the induction dose and the optimal intubation conditions (defined by accelerometry - single twitch below 10%, or TOF below 1, or post-tetanic count - PTC tracing) will be recorded
Measured: Intraoperatively
time needed for intubation
time between the induction dose and first capnography tracing will be recorded
Measured: Intraoperatively
time to reach oxygen saturation 100%
time between the preoxygenation initiation and the 100% oxygen saturation between the groups will be recorded
Measured: Intraoperatively
First intubation attempt success rate
First intubation attempt success rate
Measured: Intraoperatively
Number of intubation attempts to successful intubation
Number of intubation attempts to successful intubation
Measured: Intraoperatively
Intubation conditions
Intubation conditions defined by Cormack-Lehane score
Measured: Intraoperatively
Incidence of complications
Incidence of complications - aspiration, regurgitation, difficult intubation
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 Jun 2023
- Primary completion30 Jun 2023
- Study completion1 Jul 2025
Why it stopped: Recruitment failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Sequence Induction (RSI)Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Triple group randomized controlled pilot trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Stourac, prof. MD., Ph.D., MBA, Study chair, Department of paediatric anaesthesia and intensive care medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846919
- Sponsor's protocol ID
- KDAR PRSI-START-UP
- Acronym
- PRSIHFO
- Status last verified
- Jul 2025
- First submitted
- 17 Apr 2023
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Oxygen in Preoxygenation During Rapid Sequence Induction in Infants and Small Children: Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05846919
- Acronym / sponsor ID
- PRSIHFO / KDAR PRSI-START-UP
- Conditions
- Rapid Sequence Induction (RSI), Preoxygenation
- Keywords
- Rapid sequence induction (RSI), High flow nasal oxygenation (HFNO), High flow nasal cannula (HFNC), preoxygenation, children, pediatric, infant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment failure
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 6 May 2023 (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.
Airway management is crucial part of the anaesthesia. There is always a considerable risk of complications or even failure during the anaesthesia induction and airway management. The risk could be greater considering anaesthesia in children and neonates because of their anatomical and physiological differences. Children and neonates are more susceptible to hypoxia and bradycardia during induction of anaesthesia, this risk is even greater during the rapid sequence induction/intubation (RSI), in which there is an apnoeic pause because of the absence of manual ventilation. Because of the pause it is necessary to provide enough oxygen in advance during preoxygenation. The aim of this trial is to compare providing oxygen by face-mask and by high-flow nasal oxygen cannula. Another outcome is to evalute the safety profile RSI in children and neonates.
Detailed description
All patients requiring an acute surgery and rapid sequence induction/intubation will be checked for eligibility criteria and then an informed consent will be obtained. Afterwards, randomization will take place, which will divide a patient into one of three groups: 1) RSI + face-mask preoxygenation, 2) RSI + high-flow nasal oxygen cannula (HFNOC) preoxygenation and 3) RSI + face-mask and HFNOC preoxygenation.
The demographic data, type of surgery and vital signs will be observed. Primary outcomes will be the impact of HFNOC preoxygenation on oxygen saturation by pulse oximetry (SpO2) and heart rate during the induction of anaesthesia. Secondary outcomes will be safety of the RSI protocol, Cormack-Lehane score, incidence of difficult airway management, number of the intubation attempts and episodes of regurgitation/aspiration.
RSI will be done according to our protocol. Initially, equipment will be checked and an i.v. line will be checked/started and then a bolus of ketamine will be given (0,2-0,5 mg/kg intravenously,) for the face-mask/HFNOC tolerance and the table will be tilted to anti-Trendelenburg position. In case of difficult or unable of intravenous line insertion, intramuscular bolus of ketamin (1-3mg/kg i.m.) could be used prior to another attempt. Afterward, the preoxygenation will start according to the randomization result - group 1) face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute), group 2) HFNOC preoxygenation (flow 2 L/kg/minute, max 6 L/minute) and group 3) HFNOC (flow 2 L/kg/minute) + face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) - with 100 % oxygen for three minutes. Then a bolus of anaesthetic and myorelaxant agent will be given (propofol 2,5 mg/kg in haemodynamically stable, ketamine in haemodynamically unstable and rocuronium 1 mg/kg or suxamethonium 1,5 mg/kg if sugammadex bolus was given in last 24 hours). The neuromuscular blockade will be monitored, first intubation attempt will start as soon as single twitch will be bellow 10 % or train-of-four (TOF) bellow 1 or after 60 seconds, whichever comes first. After that, the first intubation attempt will take place, a video laryngoscopy will be used and Cormack-Lehane score will be documented photographically. The attempt will end either by successful intubation with monitored capnography wave or by failure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Triple group randomized controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients indicated for RSI and face-mask preoxygenation | Active comparator | Procedure: face-mask preoxygenationface-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes. |
| Pediatric patients indicated for RSI and HFNOC preoxygenation | Active comparator | Procedure: HFNOC preoxygenationHFNOC preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes. |
| Pediatric patients indicated for RSI and HFNOC + face-mask preoxygenation | Experimental | Procedure: HFNOC + face-mask preoxygenationHFNOC (flow 2 L/kg/minute) + face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) - with 100 % oxygen for three minutes. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients indicated for rapid sequence induction
- informed consent
Key exclusion criteria (2 listed)
- decline to participate
- rapid sequence induction not required for anesthesia induction
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 |
|---|---|---|
| face-mask preoxygenationface-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes. | Procedure or surgery | Pediatric patients indicated for RSI and face-mask preoxygenation |
| HFNOC preoxygenationHFNOC preoxygenation (flow 2 L/kg/minute, max 6 L/minute) with 100 % oxygen for three minutes. | Procedure or surgery | Pediatric patients indicated for RSI and HFNOC preoxygenation |
| HFNOC + face-mask preoxygenationHFNOC (flow 2 L/kg/minute) + face-mask preoxygenation (flow 2 L/kg/minute, max 6 L/minute) - with 100 % oxygen for three minutes. | Procedure or surgery | Pediatric patients indicated for RSI and HFNOC + face-mask preoxygenation |
Primary outcome
Incidence of desaturation under 90%
Time frame: Intraoperatively
peripheral oxygen saturation measured by saturation probe will be evaluated and the saturation at the moment of first successful intubation attempt (defined by the first capnography tracing), the incidence of saturation declined below 90% will be recorded
Incidence of manual ventilation during RSI
Time frame: Intraoperatively
incidence of manual ventilation during preoxygenation due to desaturation will be evaluated
10 secondary outcomes
Incidence of desaturation under 80%
Time frame: Intraoperatively
time to desaturation under 90%
Time frame: Intraoperatively
time to desaturation under 80%
Time frame: Intraoperatively
time needed for relaxation
Time frame: Intraoperatively
time needed for intubation
Time frame: Intraoperatively
time to reach oxygen saturation 100%
Time frame: Intraoperatively
First intubation attempt success rate
Time frame: Intraoperatively
Number of intubation attempts to successful intubation
Time frame: Intraoperatively
Intubation conditions
Time frame: Intraoperatively
Incidence of complications
Time frame: Intraoperatively
Results and safety
The study was stopped early (reason given: Recruitment failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Petr Stourac, prof. MD., Ph.D., MBA study chair
Department of paediatric anaesthesia and intensive care medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing face-mask preoxygenation, HFNOC preoxygenation and HFNOC + face-mask preoxygenation in people with Rapid Sequence Induction (RSI) and Preoxygenation, run by Brno University Hospital at 1 site in Czechia.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 3 Aug 2025. 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 Czechia. 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?
The study was stopped early (reason given: Recruitment failure). Results are not available in the source record.
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?
Incidence of desaturation under 90% (time frame: Intraoperatively). The study lists 2 primary outcomes in all. 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 3 Aug 2025.