Actively Recruiting
Led by University Hospital Heidelberg · Updated on 2025-03-03
200
Participants Needed
1
Research Sites
17 weeks
Total Duration
Researchers are evaluating the effectiveness of apnoeic oxygenation during pediatric anesthesia to prevent low oxygen levels in children undergoing surgery. This randomized, controlled, single-blinded clinical trial focuses on infants up to 24 months and children aged 2 to 6 years. The study aims to compare oxygen levels and intubation success between children receiving apnoeic oxygenation and those who do not, addressing risks like hypoxaemia that can lead to serious complications. Participants are divided into two age groups, each with 100 children randomized equally into intervention and control groups. The intervention group receives apnoeic oxygenation via nasal cannula during anesthesia induction, supplementing standard care, while the control group undergoes standard anesthesia induction without it. This setup allows evaluation of how apnoeic oxygenation may extend safe apnea time and improve airway management. During the study, researchers will monitor the lowest oxygen saturation (SpO2) during apnea and assess intubation success, time to intubation, oxygen desaturation timing, heart rate, blood pressure changes, and anesthesia-related adverse events. These measurements occur during anesthesia induction and airway management. The total participation covers the surgical procedure period with close monitoring of respiratory and cardiovascular responses.
CONDITIONS
Apnoeic Oxygenation During Pediatric Tracheal Intubation
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During induction of anaesthesia and subsequent airway management
Participants receive standard induction of anaesthesia, with some receiving additional apnoeic oxygenation via nasal cannula to potentially prolong safe apnoea time during airway management.
1 treatment session (in-person)
Total: 1 location
1
Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
D
Davut Deniz Uzun, Dr. /MD
F
Felix Schmitt, Assoc. Professor.
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Davut Deniz Uzun, Benjamin P Zimmermann, Sebastian Knoeller...
https://pubmed.ncbi.nlm.nih.gov/40316345