ClinConnect ClinConnect Logo
Search / Trial NCT06576596

Apnoeic Oxygenation During Pediatric Tracheal Intubation

Launched by UNIVERSITY HOSPITAL HEIDELBERG · Aug 26, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Airway Management Pediatric Anesthesia Apnoeic Oxygenation Apneic Oxygenation Oxygen Tracheal Intubation

ClinConnect Summary

This clinical trial is looking at a method called apnoeic oxygenation, which may help improve safety during anesthesia in young children undergoing surgery. The main aim is to see how well this method keeps oxygen levels stable when children are being intubated, which means placing a tube to help them breathe during the procedure. The study will involve two groups of children: infants up to 2 years old and children between 2 and 6 years old. Each group will be split in half, with one half receiving the apnoeic oxygenation and the other half not, allowing researchers to compare the outcomes.

To participate, children need to be between 0 and 6 years old and scheduled for elective surgery with general anesthesia. However, children with certain health issues, those needing emergency care, or who have specific medical conditions that may complicate the use of the study method won’t be included. Families who choose to participate will help researchers understand whether this technique can lead to safer anesthesia experiences for children. It's important to note that the study is currently recruiting participants, so there may be opportunities for eligible families to get involved.

Gender

ALL

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

About University Hospital Heidelberg

University Hospital Heidelberg is a leading academic medical center in Germany, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a key player in translational medicine, the hospital integrates cutting-edge scientific discoveries with patient care, facilitating a robust environment for clinical trials. With a diverse range of specialties and a multidisciplinary approach, University Hospital Heidelberg aims to improve therapeutic outcomes and enhance the quality of life for patients through evidence-based practices. The institution is dedicated to fostering collaborations with academic partners, industry stakeholders, and regulatory bodies to drive forward-looking research initiatives and contribute to the global medical community.

Locations

Heidelberg, Baden Wuerttemberg, Germany

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported