Status:
UNKNOWN
Apneic Intubation Critically Ill Children
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University Hospital, Geneva
State Hospital, St. Gallen
Conditions:
Airway Management
Eligibility:
All Genders
37-6 years
Phase:
NA
Brief Summary
This study compares the actual standard of care of intubation in Swiss pediatric intensive care units vs the use of apneic oxygenation using either high flow or low flow oxygen to prevent hypoxemia an...
Detailed Description
Randomized controlled multicenter trial in Swiss pediatric ICUs with randomization to 3 groups: 1) standard of care with conventional preoxygenation with bag-mask ventilation vs 2) conventional preoxy...
Eligibility Criteria
Inclusion
- Pediatric patients requiring intubation in the pediatric intensive care unit
- Aged from 37 weeks corrected gestational age to 6 years
- Legal guardians providing written informed consent before the intervention or delayed consent in the event that emergency intubation is required
Exclusion
- Patients with known or suspected difficult/airways
- Congenital heart disease mandating FiO2 \< 1.0, warranting inhalational induction, requiring ongoing CPR or advanced life support due to respiratory arrest
- Preterm age \< 37 0/7 weeks
- Patients who cannot be intubated orally
- Respiratory insufficiency with an SpO2 saturation \< 90 % after 2 min of preoxygenation with FiO2 = 1.0
- Newborns requiring surfactant within the first 3 days of life
- Document stating intent to reject participation in research projects or refusal of intubation or refusal of resuscitation measures
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04890288
Start Date
June 1 2021
End Date
December 31 2023
Last Update
June 3 2021
Active Locations (7)
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1
EOC
Bellinzona, Switzerland
2
Inselspital
Bern, Switzerland
3
Kantonsspital
Chur, Switzerland
4
HUG
Geneva, Switzerland