Actively Recruiting

Phase Not Applicable
Age: 0Years - 6Years
All Genders
NCT06576596

Apnoeic Oxygenation During Pediatric Tracheal Intubation

Led by University Hospital Heidelberg · Updated on 2025-03-03

200

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Apnoeic Oxygenation During Pediatric Tracheal Intubation

Who Can Participate

Age: 0Years - 6Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 0 to 6 years
  • ASA (American Society of Anesthesiologists) status I to III
  • Scheduled for elective surgery or intervention under general anesthesia
Not Eligible

You will not qualify if you...

  • Refusal to participate by patients or legal guardians
  • ASA classification IV indicating life-threatening disease
  • Receiving oxygen therapy before surgery
  • Surgery or intervention in the ear, nose, and throat (ENT) area with contraindication for oxygen goggles
  • Injuries or trauma in the ENT or mouth/nose area
  • Anatomical anomalies or malformations in the ENT or mouth/nose area
  • Chronic hypoxemia such as cyanotic heart disease
  • Language barrier with parent or guardian
  • Emergency interventions
  • Refusal by the attending physician
  • Absence of pediatric anesthesiology consultant
  • Situational inability to perform apnoeic oxygenation or obtain baseline NIRS values due to patient agitation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,

Heidelberg, Baden-Wurttemberg, Germany, 69120

Actively Recruiting

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Research Team

D

Davut Deniz Uzun, Dr. /MD

CONTACT

F

Felix Schmitt, Assoc. Professor.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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