NCT05967507 Laryngoscopy for Neonatal and Infant Airway Management wIth Supplemental Oxygen at Different Flow Rates (OPTIMISE-2)
| NCT ID | NCT05967507 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Thomas Riva |
| Condition | Airway Management |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,192 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,192 participants in total. It began in 2023-12-01 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Thomas Riva, MD
STUDY CHAIR
University of Bern
Frequently Asked Questions
Who can join the NCT05967507 clinical trial?
This trial is open to participants of all sexes, up to 52 Weeks, studying Airway Management. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05967507 currently recruiting?
Yes, NCT05967507 is actively recruiting participants. Contact the research team at alexander.fuchs@insel.ch for enrollment information.
Where is the NCT05967507 trial being conducted?
This trial is being conducted at Philadelphia, United States, Perth, Australia, São Paulo, Brazil, Toronto, Canada and 7 additional locations.
Who is sponsoring the NCT05967507 clinical trial?
NCT05967507 is sponsored by Thomas Riva. The principal investigator is Thomas Riva, MD at University of Bern. The trial plans to enroll 1,192 participants.