Status:
WITHDRAWN
Optiflow vs. Convential Anesthesia During Pediatric Laryngeal Papilloma Removal
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Conditions:
Laryngeal Papilloma, Recurrent
Eligibility:
All Genders
2-17 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a randomized cross over study of high flow oxygen delivery via nasal cannula vs. conventional tubeless anesthesia for patients undergoing dubulking surgery for laryngeal papilloma. Ten patient...
Detailed Description
This trial will be a randomized unmasked open-label study of Transnasal humidified high-flow oxygen/air delivery compared to conventional tubeless anesthesia during airway surgery in pediatric patient...
Eligibility Criteria
Inclusion
- Diagnosis of laryngeal papilloma via endoscopic exam by a pediatric ENT surgeon. And the expectation that he or she will require multiple debulking surgeries.
- Age 2-17 years old at time of consent and both surgeries.
- Parent/guardian consent and patient assent has been given.
Exclusion
- Patients with nasal obstructions or are otherwise not candidates for high flow oxygen delivery via nasal cannula.
- Patients with underlying complicating pulmonary diseases like severe asthma, pulmonary hypertension, or ongoing pneumonia.
- Pregnant patients.
- Absence of parent or legal guardian able to provide written consent.
- Patients who in the opinion of the investigator would not be good candidates for debulking surgery.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05215249
Start Date
February 1 2022
End Date
December 1 2025
Last Update
January 31 2022
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