Status:
COMPLETED
Laryngoscopy for Neonatal and Infant aIrway Management (Optimise-Trial)
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University of Bern
Gaslini Children's Hospital
Conditions:
Airway Management
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief Summary
The objective of this study is to compare tracheal intubation first attempt success rate with the C-MAC indirect videolaryngoscope (Karl Storz, Germany) using a Miller-Blade nr 0 or nr 1 compared to a...
Detailed Description
Eligible children will be prepared for intubation according to the local SOPs of the pediatric anesthesia or pediatric intensive care departments. Mandatory monitoring will consist of: SpO2, HR, NIBP....
Eligibility Criteria
Inclusion
- Pediatric patients requiring tracheal intubation for elective, semi-elective or urgent surgical and non-surgical indications either in the pediatric operating room, the pediatric or neonatal intensive care unit
- Children aged up to 52 weeks (corrected gestational 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 mandating FiO2 \< 1.0
- cardiopulmonary collapse requiring advanced life support
- intubation for emergency surgical and non-surgical indications
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2023
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04295902
Start Date
April 1 2020
End Date
March 8 2023
Last Update
March 9 2023
Active Locations (1)
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1
University Hospital Bern
Bern, Switzerland, 3010