Apnoeic Oxygenation During Pediatric Tracheal Intubation

ConditionsAnesthesia Airway Complication of Anesthesia Anesthesia; Adverse Effect

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age0-6

SponsorUniversity Hospital Heidelberg

About this 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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

children 0-6 years

ASA status I-III

Elective surgery/intervention under general anaesthesia

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

apnoeic Oxygenation
Other intervention
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.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Standard induction of anaesthesia in the child.No intervention 0 interventions

Group B: Experimental group: standard induction is supplemented by apnoeic oxygenation.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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'.

Time frame