Optiflow vs. Convential Anesthesia During Pediatric Laryngeal Papilloma Removal
NCT ID: NCT05215249
Last Updated: 2022-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2022-02-28
2025-12-31
Brief Summary
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Detailed Description
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Two study arms will be used in this study. Subjects will be treated with both study arms over the course of two study visits. Enrolled patients will be patients that present themselves routinely for removal of laryngeal papilloma. These patients, once enrolled, will be randomized to either receive conventional tubeless anesthesia or standard anesthesia with the addition of transnasal high-flow oxygen/air for their next scheduled anesthetic. Oxygen flows for the high-flow nasal cannula will be titrated down to achieve a FiO2 value of 21% during lasering. The anesthesia method not chosen will be used for the following anesthetic for each patient. Intraoperatively patients will be monitored for number of desaturations below 90 percent, length of these desaturations and severity, number and type of interventions necessary by the anesthesiologist, and number of intubations necessary by the anesthesiologist. Flow rates appropriate for the age of the patient will be used and also be recorded within these cases. Adverse events and complications will also be recorded for both anesthetics.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Standard of Care
Patient will receive conventional tubeless anesthesia
No interventions assigned to this group
High Flow Oxygen Delivery
Patient will receive Transnasal humidified high-flow oxygen delivery (Optiflow)
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 2-17 years old at time of consent and both surgeries.
3. Parent/guardian consent and patient assent has been given.
Exclusion Criteria
2. Patients with underlying complicating pulmonary diseases like severe asthma, pulmonary hypertension, or ongoing pneumonia.
3. Pregnant patients.
4. Absence of parent or legal guardian able to provide written consent.
5. Patients who in the opinion of the investigator would not be good candidates for debulking surgery.
2 Years
17 Years
ALL
No
Sponsors
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Massachusetts Eye and Ear Infirmary
OTHER
Responsible Party
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Nita Sahani
Principal Investigator
Other Identifiers
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2019P001552
Identifier Type: -
Identifier Source: org_study_id