WithdrawnPhase 1/2

Optiflow vs. Convential Anesthesia During Pediatric Laryngeal Papilloma Removal

Stopped: IRB approval not received

0Started 2022-02

Plain-language 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 patients aged 2-17 with laryngeal papilloma that are eligible for debulking surgery will be consented and enrolled.

Who can participate

Age range2 Years – 17 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Primary Endpoint

Timeframe: End of study

Trial details

NCT IDNCT05215249

SponsorMassachusetts Eye and Ear Infirmary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Laryngeal Papilloma, Recurrent trials