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Laryngoscopy for Neonatal and Infant Airway Management wIth Supplemental Oxygen at Different Flow Rates (OPTIMISE-2)
Sponsor: Thomas Riva
Summary
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.
Official title: Laryngoscopy for Neonatal and Infant Airway Management wIth Supplemental Oxygen at Different Flow Rates (OPTIMISE-2): a Multi-center, Non-inferiority, Prospective Randomized Controlled Trial
Key Details
Gender
All
Age Range
Any - 52 Weeks
Study Type
INTERVENTIONAL
Enrollment
1192
Start Date
2023-12-01
Completion Date
2027-09
Last Updated
2026-05-12
Healthy Volunteers
No
Conditions
Interventions
Low-flow nasal supplemental oxygen with a conventional nasal cannula during tracheal intubation with the C-MAC video laryngoscope
0.2 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
2 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.
Locations (11)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Perth Children's Hospital
Perth, Western Australia, Australia
Hospital Municipal Infantil Menino Jesus, Servicos Medicos de Anestesia
São Paulo, São Paulo, Brazil
Dept. Anesthesia, The Hospital for Sick Children
Toronto, Ontario, Canada
Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre
Montreal, Canada
Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin
Berlin, Germany
IRCCS Istituto Giannina Gaslini
Genova, Italy
Kantonsspital Aarau, KSA
Aarau, Canton of Aargau, Switzerland
Luzerner Kantonsspital
Lucerne, Canton of Lucerne, Switzerland
Inselspital
Bern, Switzerland
CHUV Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland