Status:
RECRUITING
Apnoeic Oxygenation During Pediatric Tracheal Intubation
Lead Sponsor:
University Hospital Heidelberg
Conditions:
Anesthesia
Airway Complication of Anesthesia
Eligibility:
All Genders
Up to 6 years
Phase:
NA
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: primar...
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 critic...
Eligibility Criteria
Inclusion
- children 0-6 years
- ASA status I-III
- Elective surgery/intervention under general anaesthesia
Exclusion
- 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
Key Trial Info
Start Date :
September 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06576596
Start Date
September 9 2024
End Date
August 31 2025
Last Update
March 3 2025
Active Locations (1)
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1
Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,
Heidelberg, Baden-Wurttemberg, Germany, 69120