Optiflow vs. Convential Anesthesia During Pediatric Laryngeal Papilloma Removal
Primary Purpose
Laryngeal Papilloma, Recurrent
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Transnasal humidified high-flow oxygen delivery
Sponsored by
About this trial
This is an interventional treatment trial for Laryngeal Papilloma, Recurrent
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care
High Flow Oxygen Delivery
Arm Description
Patient will receive conventional tubeless anesthesia
Patient will receive Transnasal humidified high-flow oxygen delivery (Optiflow)
Outcomes
Primary Outcome Measures
Primary Endpoint
The primary objective of this study is to investigate the effects of transnasal humidified high-flow oxygen/air system to maintain safe intraoperative oxygen saturations in pediatric patients undergoing procedures for removal of laryngeal papilloma, thereby improving the quality of care. Number, duration and severity of intraoperative desaturations below 90 percent.
Secondary Outcome Measures
Full Information
NCT ID
NCT05215249
First Posted
February 21, 2020
Last Updated
January 18, 2022
Sponsor
Massachusetts Eye and Ear Infirmary
1. Study Identification
Unique Protocol Identification Number
NCT05215249
Brief Title
Optiflow vs. Convential Anesthesia During Pediatric Laryngeal Papilloma Removal
Official Title
Transnasal Humidified High-Flow Oxygen Delivery (Optiflow) vs. Conventional Tubeless Anesthesia for the Prevention of Desaturations During Pediatric Laryngeal Papilloma Removal
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Withdrawn
Why Stopped
IRB approval not received
Study Start Date
February 2022 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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 patients aged 2-17 with laryngeal papilloma that are eligible for debulking surgery will be consented and enrolled.
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 patients. This will be a single center study at MEE main campus on 243 Charles St, Boston, MA for the use of the high-flow oxygen delivery device.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Papilloma, Recurrent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Model Description
randomized crossover study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Patient will receive conventional tubeless anesthesia
Arm Title
High Flow Oxygen Delivery
Arm Type
Experimental
Arm Description
Patient will receive Transnasal humidified high-flow oxygen delivery (Optiflow)
Intervention Type
Procedure
Intervention Name(s)
Transnasal humidified high-flow oxygen delivery
Other Intervention Name(s)
Optiflow
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Endpoint
Description
The primary objective of this study is to investigate the effects of transnasal humidified high-flow oxygen/air system to maintain safe intraoperative oxygen saturations in pediatric patients undergoing procedures for removal of laryngeal papilloma, thereby improving the quality of care. Number, duration and severity of intraoperative desaturations below 90 percent.
Time Frame
End of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Optiflow vs. Convential Anesthesia During Pediatric Laryngeal Papilloma Removal
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