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Laryngoscopy for Neonatal and Infant Airway Management wIth Supplemental Oxygen at Different Flow Rates (OPTIMISE-2)

RecruitingNAAges any - 52 WeeksAllThomas Riva
NCT05967507 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
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What it tests

  • Low-flow nasal supplemental oxygen with a conventional nasal cannula during tracheal intubation with the C-MAC video laryngoscope
  • High-flow nasal supplemental oxygen (Fisher & Paykel, Auckland, New Zealand) during tracheal intubation with the C-MAC video laryngoscope
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Where

11 sites
Children's Hospital of Philadelphia
Philadelphia, United States
Perth Children's Hospital
Perth, Australia
Hospital Municipal Infantil Menino Jesus, Servicos Medicos de Anestesia
São Paulo, Brazil
Dept. Anesthesia, The Hospital for Sick Children
Toronto, 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, Switzerland

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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