Optimizing oxygen flow rates during intubation in neonates and infants
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
Run by Insel Gruppe AG, University Hospital Bern · NCT05967507 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | Any age to 52 Weeks |
| Sex | All |
| Enrollment | 1192 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 11 sites (Philadelphia, Pennsylvania and 10 other locations) |
| Status | Recruiting |
| Started | December 1, 2023 |
| Main results expected | June 2027 |
| Study ends | September 2027 |
| Registry record updated | May 12, 2026 |
| Trial ID | NCT05967507 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are neonates and infants up to 52 weeks postconceptual age requiring tracheal intubation for various surgical and non-surgical reasons.
✕Probably not a fit
Patients with a predicted difficult intubation or those requiring advanced life support will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have explored oxygen flow rates in airway management, but this specific approach is novel in the context of pediatric intubation.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
Show 5 more locations
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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
- Email: alexander.fuchs@insel.ch
- Phone: +41 31 632 52 01
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Ultrasound Measurements and Age-Related Anatomy to Guide LMA Placement
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I-scoop vs C-Mac D-Blade for airway management with spontaneous breathing
This study tests whether the i-scoop videolaryngoscope makes airway management with the patient breathing on their own and light sedation easier and safer than the C-Mac D-Blade in adults having surgery under general anesthesia.
-
Comparing two videolaryngoscopes for placing breathing tubes in infants
This trial will test whether the BESDATA BD-DF videolaryngoscope works as well as the McGRATH MAC for placing breathing tubes on the first try in infants aged 6 months to 3 years during elective surgery.
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This test tries to find the ventilation pressure during anesthesia induction that prevents air from entering the esophagus in adults having elective general surgery.
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This project will test whether the SaCoVLM™ video laryngeal mask helps military medics with limited intubation experience manage airways safely during simulation and in sedated elective surgery patients.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.