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Optiflow vs. Convential Anesthesia During Pediatric Laryngeal Papilloma Removal

NCT05215249 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2022-01-31

No results posted yet for this study

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.

Conditions

  • Laryngeal Papilloma, Recurrent

Interventions

PROCEDURE

Transnasal humidified high-flow oxygen delivery

The Optiflow system consists of an apparatus that is capable of delivering humidified oxygen, room air, or a mixture of variable oxygen concentration. The oxygen concentration can be precisely varied from 21-100% (or 0.21 - 1.00 FiO2). The gas is warmed to 37°C with a 100% relative humidity. The humidified and warmed gas can be delivered to the patient at high-flows (up to 70 L/min) using various delivery mechanisms. The investigators will be using a nasal cannula to deliver high flow oxygen (2-3 L/kg/min) to the patient.

Sponsors & Collaborators

  • Massachusetts Eye and Ear Infirmary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2025-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05215249 on ClinicalTrials.gov