Clinical trial Recruiting at 10 sites Interventional Ages Any age to 52 Weeks

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 typeInterventional
AgesAny age to 52 Weeks
SexAll
Enrollment1192 (estimated)
SponsorInsel Gruppe AG, University Hospital Bern
Academic / other
Locations11 sites (Philadelphia, Pennsylvania and 10 other locations)
StatusRecruiting
StartedDecember 1, 2023
Main results expectedJune 2027
Study endsSeptember 2027
Registry record updatedMay 12, 2026
Trial IDNCT05967507 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.