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
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: f
View:
• 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
Locations
United States
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Other Locations
Australia
Perth Children's Hospital
RECRUITING
Perth
Brazil
Hospital Municipal Infantil Menino Jesus, Servicos Medicos de Anestesia
RECRUITING
São Paulo
Canada
Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre
RECRUITING
Montreal
Dept. Anesthesia, The Hospital for Sick Children
RECRUITING
Toronto
Germany
Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin
RECRUITING
Berlin
Italy
IRCCS Istituto Giannina Gaslini
RECRUITING
Genova
Switzerland
Kantonsspital Aarau, KSA
RECRUITING
Aarau
Inselspital
RECRUITING
Bern
CHUV Centre Hospitalier Universitaire Vaudois
ACTIVE_NOT_RECRUITING
Lausanne
Luzerner Kantonsspital
RECRUITING
Lucerne
Contact Information
Primary
Alexander Fuchs, MD
alexander.fuchs@insel.ch
+41 31 632 52 01
Backup
Thomas Riva, MD
thomasriva@me.com
+41 31 632 17 09
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2027-09
Participants
Target number of participants: 1192
Treatments
Experimental: Intervention group
0.2 L/kg/min FiO2 1.0 low-flow nasal supplemental oxygen with conventional nasal cannula during tracheal intubation performed with the C-MAC videolaryngoscope (Karl Storz, Tuttlingen, Germany) with Miller-blade or Macintosh-blade size No. 0 or No. 1.
Active_comparator: Control group
2 L/kg/min FiO2 1.0 high-flow nasal supplemental oxygen with the Optiflow (Fisher \& Paykel Healthcare, Auckland, New Zealand) during tracheal intubation performed with the C-MAC videolaryngoscope (Karl Storz, Tuttlingen, Germany) with Miller-blade or Macintosh-blade size No. 0 or No. 1.
Related Therapeutic Areas
Sponsors
Collaborators: Centre Hospitalier Universitaire Vaudois, Istituto Giannina Gaslini, University Hospital, Geneva, Charite University, Berlin, Germany, Perth Children's Hospital, Cantonal Hospital of Lucerne, Montreal Children's Hospital of the MUHC, Children's Hospital of Philadelphia, Kantonsspital Aarau, The Hospital for Sick Children
Leads: Thomas Riva