AnesthesiaNCT06576596
Apnoeic Oxygenation During Pediatric Tracheal Intubation
A study testing apnoeic Oxygenation in people with Anesthesia and Airway Complication of Anesthesia, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The goal of this randomized, controlled, single-blinded clinical trial is to evaluate the effectiveness of apnoeic Oxygenation in pediatric anesthesia. The main question it aims to answer are: primary outcome measure: The primary outcome will be the lowest SpO₂ value recorded during the apnoeic period. Read more about this study
- Who is it for?
- Ages 0 to 6 years
- Conditions the study is for
- Anesthesia, Airway Complication of Anesthesia, Anesthesia; Adverse Effect
- What is being tested?
- apnoeic Oxygenation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 9 Sep 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children 0-6 years
- ASA status I-III
- Elective surgery/intervention under general anaesthesia
Who cannot join
- refusal to participate in the study by the patients or their legal guardians
- ASA classification IV = patients with life-threatening disease
- Existing oxygen therapy prior to surgery
- Surgery/intervention in the ENT area with contraindication for oxygen goggles
- Injuries/trauma in the ENT and mouth/nose area
- Anatomical anomalies/malformations in the ENT and mouth/nose area
Show all 12Show fewer
- Chronical hypoxemia (e.g. patients with cyanotic heart diseases)
- language barrier (parent/guardian)
- emergency interventions
- refusal by the attending physician
- lack of presence of the pediatric anesthesiology consultant
- Situational inability to perform apnoeic oxygenation or inability to obtain baseline NIRS values at room air within 60 seconds from the first attempt due to agitation of the patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,
Heidelberg, Baden-Wurttemberg, 69120
Davut Deniz Uzun, MD, 0049 62215639349, deniz.uzun@med.uni-heidelberg.de
Felix Schmitt, MD, 0049 62215639421, Felix.Schmitt@med.uni-heidelberg.de
About this study
Official title: Apnoeic Oxygenation During Pediatric Tracheal Intubation: a Study Protocol for a Single-center, Cluster Randomized Clinical Trial (ApOx-Pedi-Trial)
The goal of this randomized, controlled, single-blinded clinical trial is to evaluate the effectiveness of apnoeic Oxygenation in pediatric anesthesia. The main question it aims to answer are:
primary outcome measure: The primary outcome will be the lowest SpO₂ value recorded during the apnoeic period.
Read more
secondary outcome measure:
- Differences in intubation first-pass-success (key secondary objective)
- Temporal differences to achieve successful intubation
- Differences in time to oxygen desaturation
- Differences in heart rate and mean arterial blood pressure decrease
- Differences in the incidence of anesthesia-related adverse events
The study participants are randomized two age dependents groups. Either in the control group without the use of apnoeic oxygenation or in the intervention group with the use of apnoeic oxygenation.
The study population will be divided into two independent cohorts, each consisting of 100 patients. The first cohort, designated as "infants" will include all patients aged up to 24 months, while the second cohort, termed "children" will comprise patients aged older than 24 months and up to six years.
Within each cohort, patients will be randomized into an intervention group and a control group, with 50 patients assigned to each. This randomization will ensure that, for both the Infant and Children Groups, half of the participants (n=50) will receive the intervention, while the other half (n=50) will serve as controls.
Statistical analysis of primary and secondary endpoints will be conducted independently for each cohort. This stratified approach will allow for targeted evaluation of age-specific effects of the intervention, as well as comparison between intervention and control outcomes within each age-defined cohort.
Read the detailed description
The incidence of intraoperative hypoxaemia in children is high and age-dependent. An incidence of over 10 % is reported in8- to 16-year-old children and over50 % in newborns. Severe respiratory critical events occur in paediatric anaesthesia with an incidence of 3.1 %. After the onset of apnoea, hypoxaemia develops more rapidly in children than in adults, which is due to increased oxygen consumption, a lower functional residual capacity and an increased closing capacity. These events can lead to permanent neurological damage or death. One approach to preventing adverse respiratory events due to hypoxaemia during paediatric anaesthesia is the use of apnoeic oxygenation. The principle is to supply oxygen to the airways of anaesthetised patients via a conventional nasal cannula. As less carbon dioxide is produced than oxygen is consumed during apnoea, the supply of oxygen to the upper airways leads to an 'inward diffusion' of oxygen, which prolongs the time until desaturation and hypoxaemia occur. This also extends the 'safe apnoea time' and the anaesthetist has more time to secure the airway. As the incidence and severity of arterial oxygen desaturation is higher in critically ill children compared to healthy children, this vulnerable group in particular could benefit from apnoeic oxygenation. Apnoeic oxygenation is increasingly becoming a standard technique in paediatric anaesthesia, with applications ranging from induction of anaesthesia in the operating theatre and standard airway management to the management of difficult airways. In its current guidelines, the European Society of Anaesthesiology and Intensive Care recommends the use of apnoeic oxygenation in the airway management of newborns and infants. The main aim of this study is to evaluate the effectiveness of apnoeic oxygenation in terms of time to desaturation and hypoxaemia, as well as the impact of apnoeic oxygenation on intubation success in anaesthetised children.
- Being tested
- apnoeic Oxygenation
- Keywords
- Airway Management, Pediatric Anesthesia, Apnoeic Oxygenation, Apneic Oxygenation, Oxygen, Tracheal Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apnoeic OxygenationOther
One approach to preventing adverse respiratory events due to hypoxaemia during paediatric anaesthesia is the use of apnoeic oxygenation. The principle is to deliver oxygen to the airways of anaesthetised patients via a conventional nasal cannula. As less carbon dioxide is produced than oxygen is consumed during apnoea, the supply of oxygen to the upper airways leads to an 'inward diffusion' of oxygen, which may prolongs the time until desaturation and hypoxaemia occur.
| Study group | Role | What they receive |
|---|---|---|
| Standard induction of anaesthesia in the child. | No intervention | Control group: in this group, standard induction of anaesthesia is performed without the use of apnoeic oxygenation. |
| Experimental group: standard induction is supplemented by apnoeic oxygenation. | Experimental | In the experimental group, apnoeic oxygenation is used in addition to standard anaesthesia induction. Receives: Other: apnoeic Oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the lowest SpO₂ value recorded during the apnoeic period.
The main aim of anaesthesia is to avoid a drop in saturation during induction of anaesthesia. This time until the drop in oxygen saturation is described as the so-called 'safe apnoea time'.
Measured: The time frame refers only to the induction of anaesthesia and subsequent airway management.
Secondary outcomes (5)
Differences in intubation first-pass-success (key secondary outcome)
Differences in the 'first-pass-succes' of intubation between the two groups are highlighted here.
Measured: The time frame refers only to the induction of anaesthesia and subsequent airway management.
Temporal differences to achieve successful intubation
Comparison of the time differences for a successful intubation.
Measured: The time frame refers only to the induction of anaesthesia and subsequent airway management.
Differences in time to oxygen desaturation
Comparison of the time differences to desaturation.
Measured: The time frame refers only to the induction of anaesthesia and subsequent airway management.
Differences in heart rate and mean arterial blood pressure decrease
Comparison of the differences in heart rate and arterial blood pressure between the groups.
Measured: The time frame refers only to the induction of anaesthesia and subsequent airway management.
Differences in the incidence of anesthesia-related adverse events
Comparison of the differences of anesthesia-related adverse events between the groups.
Measured: The time frame refers only to the induction of anaesthesia and subsequent airway management.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start9 Sep 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, monocentric, single-blinded clinical trial. Intervention group: receive apnoeic oxygenation via the nose Control group: Does not receive apnoeic oxygenation (standard care)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Davut Deniz Uzun, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576596
- Sponsor's protocol ID
- ApOxHeidelberg
- Status last verified
- Feb 2025
- First submitted
- 26 Aug 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This aspect is still being clarified with the competent authority and will be announced in due course.
Publications
Uzun DD, Zimmermann BP, Knoeller S, Kirchner M, Mohr S, Weigand MA, Zivkovic AR, Schmitt FCF. Apnoeic oxygenation during paediatric tracheal intubation: a study protocol for a single-centre, cluster randomised clinical trial (ApOx-Pedi-Trial). BMJ Open. 2025 May 2;15(5):e096842. doi: 10.1136/bmjopen-2024-096842.
PubMed 40316345
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apnoeic Oxygenation During Pediatric Tracheal Intubation: a Study Protocol for a Single-center, Cluster Randomized Clinical Trial (ApOx-Pedi-Trial)
- ClinicalTrials.gov ID
- NCT06576596
- Acronym / sponsor ID
- ApOxHeidelberg
- Keywords
- Airway Management, Pediatric Anesthesia, Apnoeic Oxygenation, Apneic Oxygenation, Oxygen, Tracheal Intubation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 29 Aug 2024 (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.
The goal of this randomized, controlled, single-blinded clinical trial is to evaluate the effectiveness of apnoeic Oxygenation in pediatric anesthesia. The main question it aims to answer are:
primary outcome measure: The primary outcome will be the lowest SpO₂ value recorded during the apnoeic period.
secondary outcome measure:
- Differences in intubation first-pass-success (key secondary objective)
- Temporal differences to achieve successful intubation
- Differences in time to oxygen desaturation
- Differences in heart rate and mean arterial blood pressure decrease
- Differences in the incidence of anesthesia-related adverse events
The study participants are randomized two age dependents groups. Either in the control group without the use of apnoeic oxygenation or in the intervention group with the use of apnoeic oxygenation.
The study population will be divided into two independent cohorts, each consisting of 100 patients. The first cohort, designated as "infants" will include all patients aged up to 24 months, while the second cohort, termed "children" will comprise patients aged older than 24 months and up to six years.
Within each cohort, patients will be randomized into an intervention group and a control group, with 50 patients assigned to each. This randomization will ensure that, for both the Infant and Children Groups, half of the participants (n=50) will receive the intervention, while the other half (n=50) will serve as controls.
Statistical analysis of primary and secondary endpoints will be conducted independently for each cohort. This stratified approach will allow for targeted evaluation of age-specific effects of the intervention, as well as comparison between intervention and control outcomes within each age-defined cohort.
Detailed description
The incidence of intraoperative hypoxaemia in children is high and age-dependent. An incidence of over 10 % is reported in8- to 16-year-old children and over50 % in newborns. Severe respiratory critical events occur in paediatric anaesthesia with an incidence of 3.1 %. After the onset of apnoea, hypoxaemia develops more rapidly in children than in adults, which is due to increased oxygen consumption, a lower functional residual capacity and an increased closing capacity. These events can lead to permanent neurological damage or death. One approach to preventing adverse respiratory events due to hypoxaemia during paediatric anaesthesia is the use of apnoeic oxygenation. The principle is to supply oxygen to the airways of anaesthetised patients via a conventional nasal cannula. As less carbon dioxide is produced than oxygen is consumed during apnoea, the supply of oxygen to the upper airways leads to an 'inward diffusion' of oxygen, which prolongs the time until desaturation and hypoxaemia occur. This also extends the 'safe apnoea time' and the anaesthetist has more time to secure the airway. As the incidence and severity of arterial oxygen desaturation is higher in critically ill children compared to healthy children, this vulnerable group in particular could benefit from apnoeic oxygenation. Apnoeic oxygenation is increasingly becoming a standard technique in paediatric anaesthesia, with applications ranging from induction of anaesthesia in the operating theatre and standard airway management to the management of difficult airways. In its current guidelines, the European Society of Anaesthesiology and Intensive Care recommends the use of apnoeic oxygenation in the airway management of newborns and infants. The main aim of this study is to evaluate the effectiveness of apnoeic oxygenation in terms of time to desaturation and hypoxaemia, as well as the impact of apnoeic oxygenation on intubation success in anaesthetised children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, monocentric, single-blinded clinical trial. Intervention group: receive apnoeic oxygenation via the nose Control group: Does not receive apnoeic oxygenation (standard care)
| Arm | Type | Receives |
|---|---|---|
| Standard induction of anaesthesia in the child. | No intervention | –Control group: in this group, standard induction of anaesthesia is performed without the use of apnoeic oxygenation. |
| Experimental group: standard induction is supplemented by apnoeic oxygenation. | Experimental | Other: apnoeic OxygenationIn the experimental group, apnoeic oxygenation is used in addition to standard anaesthesia induction. |
Who may qualify
- Ages
- 0 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children 0-6 years
- ASA status I-III
- Elective surgery/intervention under general anaesthesia
Key exclusion criteria (12 listed)
- refusal to participate in the study by the patients or their legal guardians
- ASA classification IV = patients with life-threatening disease
- Existing oxygen therapy prior to surgery
- Surgery/intervention in the ENT area with contraindication for oxygen goggles
- Injuries/trauma in the ENT and mouth/nose area
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 |
|---|---|---|
| apnoeic OxygenationOne approach to preventing adverse respiratory events due to hypoxaemia during paediatric anaesthesia is the use of apnoeic oxygenation. The principle is to deliver oxygen to the airways of anaesthetised patients via a conventional nasal cannula. As less carbon dioxide is produced than oxygen is consumed during apnoea, the supply of oxygen to the upper airways leads to an 'inward diffusion' of oxygen, which may prolongs the time until desaturation and hypoxaemia occur. | Other | Experimental group: standard induction is supplemented by apnoeic oxygenation. |
Primary outcome
The primary outcome will be the lowest SpO₂ value recorded during the apnoeic period.
Time frame: The time frame refers only to the induction of anaesthesia and subsequent airway management.
The main aim of anaesthesia is to avoid a drop in saturation during induction of anaesthesia. This time until the drop in oxygen saturation is described as the so-called 'safe apnoea time'.
5 secondary outcomes
Differences in intubation first-pass-success (key secondary outcome)
Time frame: The time frame refers only to the induction of anaesthesia and subsequent airway management.
Temporal differences to achieve successful intubation
Time frame: The time frame refers only to the induction of anaesthesia and subsequent airway management.
Differences in time to oxygen desaturation
Time frame: The time frame refers only to the induction of anaesthesia and subsequent airway management.
Differences in heart rate and mean arterial blood pressure decrease
Time frame: The time frame refers only to the induction of anaesthesia and subsequent airway management.
Differences in the incidence of anesthesia-related adverse events
Time frame: The time frame refers only to the induction of anaesthesia and subsequent airway management.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Derived from this study: PubMed 40316345Uzun DD, Zimmermann BP, Knoeller S, Kirchner M, Mohr S, Weigand MA, Zivkovic AR, Schmitt FCF. Apnoeic oxygenation during paediatric tracheal intubation: a study protocol for a single-centre, cluster randomised clinical trial (ApOx-Pedi-Trial). BMJ Open. 2025 May 2;15(5):e096842. doi: 10.1136/bmjopen-2024-096842.
- Individual participant dataSharing planned: Undecided. This aspect is still being clarified with the competent authority and will be announced in due course.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing apnoeic Oxygenation in people with Anesthesia and Airway Complication of Anesthesia, run by University Hospital Heidelberg at 1 site in Germany.
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 12 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: looking for participants now, as of the sponsor's last update on 3 Mar 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Davut Deniz Uzun, Dr. /MD (+49 62215639349, deniz.uzun@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be the lowest SpO₂ value recorded during the apnoeic period. (time frame: The time frame refers only to the induction of anaesthesia and subsequent airway management.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06576596, which also lists 1 linked publication.
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 Mar 2025.