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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Withdrawn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
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laryngeal Papilloma, Recurrent

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of laryngeal papilloma via endoscopic exam by a pediatric ENT surgeon. And the expectation that he or she will require multiple debulking surgeries.
  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:

  1. Patients with nasal obstructions or are otherwise not candidates for high flow oxygen delivery via nasal cannula.
  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.

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

    First Posted
    February 21, 2020
    Last Updated
    January 18, 2022
    Sponsor
    Massachusetts Eye and Ear Infirmary
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    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

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    Optiflow vs. Convential Anesthesia During Pediatric Laryngeal Papilloma Removal

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