This study aims to investigate the optimal oxygen flow rate needed during tracheal intubation with the C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) using Miller-blade or Macintosh-blade size No. 0 or No. 1 in the operating room or intensive care unit. The investigators hypothesize that the difference between low-flow and high-flow supplemental oxygen is negligible.
Pediatric patients requiring oral or nasal tracheal intubation for elective, semi-elective, or urgent surgical and non-surgical indications.
Neonates and infants up to 52 weeks postconceptual age, with legal guardians providing written informed consent before the intervention
Prediction of difficult intubation upon physical examination or previous history of difficult intubation, mandating a technique different than direct laryngoscopy to secure the airway;
Congenital heart disease demanding FiO2 < 1.0
Cardiopulmonary collapse requiring advanced life support
Intubation for emergency surgical and non-surgical indications.
Parallel
Low-flow nasal supplemental oxygen with a conventional nasal cannula during tracheal intubation with the C-MAC video laryngoscope
Device0.2 L/kg/min FiO2 1.0 low-flow nasal supplemental oxygen with a conventional nasal cannula during tracheal intubation with the C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with Miller-blade or Macintosh-blade size No. 0 or No. 1.
High-flow nasal supplemental oxygen (Fisher & Paykel, Auckland, New Zealand) during tracheal intubation with the C-MAC video laryngoscope
Device2 L/kg/min FiO2 1.0 high-flow nasal supplemental oxygen (Fisher \& Paykel, Auckland, New Zealand) during tracheal intubation with the C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with Miller-blade or Macintosh-blade size No. 0 or No. 1.
First attempt success rate
The primary study outcome is to evaluate the first attempt success rate of oral and nasal tracheal intubation with the C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with supplemental oxygen with low-flow vs high flow among neonates and infants up to 52 weeks postconceptual age. A successful tracheal intubation (ETI) attempt is defined as successful placement of a tracheal tube in the trachea, confirmed by visualization of the tube passing the vocal cords, a waveform capnography suggesting correct ETT placement and auscultation of breath sounds in the lungs.
Occurrence of severe desaturation
Occurrence and duration of moderate and severe desaturation (SpO2 \< 10% and SpO2 \< 20% from baseline), with or without bradycardia, during intubation.
Overall number of intubation attempts
Overall number of intubation attempts
First attempt success rate of tracheal intubation
First attempt success rate of tracheal intubation
Time required for intubation
Time required for intubation (in seconds, defined from the first introduction of laryngoscope between the lips till successful lung ventilation defined as positive capnography)
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Thomas Riva
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Sponsor institution
University Hospital, Geneva
Collaborator
Kantonsspital Aarau
Collaborator
Centre Hospitalier Universitaire Vaudois
Collaborator
Charite University, Berlin, Germany
Collaborator
Perth Children's Hospital
Collaborator
The Hospital for Sick Children
Collaborator
Istituto Giannina Gaslini
Collaborator
Cantonal Hospital of Lucerne
Collaborator
Children's Hospital of Philadelphia
Collaborator
Montreal Children's Hospital of the MUHC
Collaborator
