Status:
RECRUITING
Laryngoscopy for Neonatal and Infant Airway Management with Supplemental Oxygen At Different Flow Rates (OPTIMISE-2)
Lead Sponsor:
Thomas Riva
Collaborating Sponsors:
University Hospital, Geneva
Kantonsspital Aarau
Conditions:
Airway Management
Eligibility:
All Genders
Up to 52 years
Phase:
NA
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 ...
Detailed Description
Eligible children will be prepared for intubation according to the local SOPs of the pediatric anesthesia departments. Mandatory monitoring will consist of: SpO2, HR, NIBP. Induction of anesthesia: I...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
1192 Patients enrolled
Trial Details
Trial ID
NCT05967507
Start Date
December 1 2023
End Date
December 1 2025
Last Update
September 19 2024
Active Locations (6)
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1
Dept. Anesthesia, The Hospital for Sick Children
Toronto, Ontario, Canada
2
Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre
Montreal, Canada
3
Deutsches Herzzentrum der Charité and Charité
Berlin, Germany, 13353
4
Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin
Berlin, Germany