Apnoeic Oxygenation During Pediatric Tracheal Intubation

NCT ID: NCT06576596

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-09
• Study Completion Date: 2025-08-31

Brief 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.

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.

Conditions

Anesthesia; Airway Complication of Anesthesia; Anesthesia; Adverse Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard induction of anaesthesia in the child.

Control group: in this group, standard induction of anaesthesia is performed without the use of apnoeic oxygenation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental group: standard induction is supplemented by apnoeic oxygenation.

In the experimental group, apnoeic oxygenation is used in addition to standard anaesthesia induction.

Group Type: EXPERIMENTAL

apnoeic Oxygenation

Intervention Type: OTHER

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.

Interventions

apnoeic Oxygenation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• children 0-6 years
• ASA status I-III
• Elective surgery/intervention under general anaesthesia

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Davut Deniz Uzun

Resident Departement of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,

Heidelberg, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Davut Deniz Uzun, Dr. /MD

Role: CONTACT

deniz.uzun@med.uni-heidelberg.de

+49 62215639349

Felix Schmitt, Assoc. Professor.

Role: CONTACT

Felix.Schmitt@med.uni-heidelberg.de

+49 6221-56 394 21

Facility Contacts

Davut Deniz Uzun, MD

Role: primary

deniz.uzun@med.uni-heidelberg.de

0049 62215639349

Felix Schmitt, MD

Role: backup

Felix.Schmitt@med.uni-heidelberg.de

0049 62215639421

References

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.

Reference Type: DERIVED

PMID: 40316345 (View on PubMed)

Other Identifiers

ApOxHeidelberg

Identifier Type: -

Identifier Source: org_study_id