Optimizing oxygen flow rates during intubation in neonates and infants

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

This study tests whether using low or high oxygen flow rates during intubation helps newborns and infants breathe better and have safer outcomes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1192 (estimated)
• Ages: N/A to 52 Weeks
• Sex: All
• Sponsor: Insel Gruppe AG, University Hospital Bern (other)
• Locations: 11 sites (Philadelphia, Pennsylvania and 10 other locations)
• Trial ID: NCT05967507 on ClinicalTrials.gov

What this trial studies

This study investigates the optimal oxygen flow rate during tracheal intubation in neonates and infants using the C-MAC video laryngoscope. It compares low-flow and high-flow supplemental oxygen to determine if there is a significant difference in outcomes. Eligible participants will undergo pre-oxygenation and anesthesia induction before intubation, with careful monitoring of vital signs throughout the procedure. The study aims to enhance airway management practices in pediatric anesthesia.

Who should consider this trial

Good fit: Ideal candidates are neonates and infants up to 52 weeks postconceptual age requiring tracheal intubation for various surgical and non-surgical reasons.

Not a fit: Patients with a predicted difficult intubation or those requiring advanced life support will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the safety and effectiveness of airway management in neonates and infants during intubation.

How similar studies have performed: Other studies have explored oxygen flow rates in airway management, but this specific approach is novel in the context of pediatric intubation.

Eligibility criteria

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.

Where this trial is running

Philadelphia, Pennsylvania and 10 other locations

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (RECRUITING)
• Perth Children's Hospital — Perth, Western Australia, Australia (RECRUITING)
• Hospital Municipal Infantil Menino Jesus, Servicos Medicos de Anestesia — São Paulo, São Paulo, Brazil (RECRUITING)
• Dept. Anesthesia, The Hospital for Sick Children — Toronto, Ontario, Canada (RECRUITING)
• Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre — Montreal, Canada (RECRUITING)
• Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin — Berlin, Germany (RECRUITING)
• IRCCS Istituto Giannina Gaslini — Genova, Italy (RECRUITING)
• Kantonsspital Aarau, KSA — Aarau, Canton of Aargau, Switzerland (RECRUITING)
• Luzerner Kantonsspital — Lucerne, Canton of Lucerne, Switzerland (RECRUITING)
• Inselspital — Bern, Switzerland (RECRUITING)
• CHUV Centre Hospitalier Universitaire Vaudois — Lausanne, Switzerland (ACTIVE_NOT_RECRUITING)

Study contacts

• Study coordinator: Alexander Fuchs, MD

Conditions: Airway Management