Laryngoscopy for Neonatal and Infant Airway Management wIth Supplemental Oxygen at Different Flow Rates (OPTIMISE-2)
Recruiting now · Not applicable
Conditions studied: Airway Management
In brief
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.
Key facts
- Study ID
- NCT05967507
- Run by
- Thomas Riva
- People needed
- 1192
- Starts
- 2023-12-01
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-05-12
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
- Perth Children's Hospital — Perth, Western Australia, Australia (enrolling)
- Hospital Municipal Infantil Menino Jesus, Servicos Medicos de Anestesia — São Paulo, São Paulo, Brazil (enrolling)
- Dept. Anesthesia, The Hospital for Sick Children — Toronto, Ontario, Canada (enrolling)
- Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre — Montreal, Canada (enrolling)
- Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin — Berlin, Germany (enrolling)
- IRCCS Istituto Giannina Gaslini — Genova, Italy (enrolling)
- Kantonsspital Aarau, KSA — Aarau, Canton of Aargau, Switzerland (enrolling)
- Luzerner Kantonsspital — Lucerne, Canton of Lucerne, Switzerland (enrolling)
- Inselspital — Bern, Switzerland (enrolling)
- CHUV Centre Hospitalier Universitaire Vaudois — Lausanne, Switzerland
Full record on ClinicalTrials.gov
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