Apnoeic Oxygenation During Pediatric Tracheal Intubation

NCT06576596 | Recruiting DMC

• 1 other identifier: ApOxHeidelberg
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Airway Complication of Anesthesia; Anesthesia; Adverse Effect

Keywords

Airway Management; Pediatric Anesthesia; Apnoeic Oxygenation; Apneic Oxygenation; Oxygen; Tracheal Intubation

Outcome Measures

Primary Outcomes (1)

• 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'.

  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)

  The time frame refers only to the induction of anaesthesia and subsequent airway management.

• Temporal differences to achieve successful intubation

  The time frame refers only to the induction of anaesthesia and subsequent airway management.

• Differences in time to oxygen desaturation

  The time frame refers only to the induction of anaesthesia and subsequent airway management.

• Differences in heart rate and mean arterial blood pressure decrease

  The time frame refers only to the induction of anaesthesia and subsequent airway management.

• Differences in the incidence of anesthesia-related adverse events

  The time frame refers only to the induction of anaesthesia and subsequent airway management.

Study Arms (2)

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.

Other: apnoeic Oxygenation

Interventions

apnoeic Oxygenation 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.

Experimental group: standard induction is supplemented by apnoeic oxygenation.

Eligibility Criteria

• Age: 0 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 40316345 DERIVED

Central Study Contacts

Davut Deniz Uzun, Dr. /MD

CONTACT

+49 62215639349; deniz.uzun@med.uni-heidelberg.de

Felix Schmitt, Assoc. Professor.

CONTACT

+49 6221-56 394 21; Felix.Schmitt@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The parents and the child are completely blinded to the study (Child is under anaesthesia, parents are not in the operating theatre). The study is also analysed by a blinded employee of Heidelberg University Hospital, Germany.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Departement of Anesthesiology

Model Details: prospective, monocentric, single-blinded clinical trial. Intervention group: receive apnoeic oxygenation via the nose Control group: Does not receive apnoeic oxygenation (standard care)

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: September 9, 2024
• Primary Completion: April 30, 2025
• Study Completion: August 31, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

DE (1)