Laryngeal Papilloma, RecurrentPhase 1/2NCT05215249
Optiflow vs. Convential Anesthesia During Pediatric Laryngeal Papilloma Removal
A Phase 1/2 study testing Transnasal humidified high-flow oxygen delivery in people with Laryngeal Papilloma, Recurrent, run by Massachusetts Eye and Ear Infirmary.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Laryngeal Papilloma, Recurrent
- What is being tested?
- Transnasal humidified high-flow oxygen delivery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Transnasal Humidified High-Flow Oxygen Delivery (Optiflow) vs. Conventional Tubeless Anesthesia for the Prevention of Desaturations During Pediatric Laryngeal Papilloma Removal
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.
Read the 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.
- Conditions
- Laryngeal Papilloma, Recurrent
- Being tested
- Transnasal humidified high-flow oxygen delivery
- Medical subject headings
- Recurrent respiratory papillomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal humidified high-flow oxygen deliveryProcedure or surgery
Also called Optiflow
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Patient will receive conventional tubeless anesthesia |
| High Flow Oxygen Delivery | Experimental | Patient will receive Transnasal humidified high-flow oxygen delivery (Optiflow) Receives: Procedure: Transnasal humidified high-flow oxygen delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study startFeb 2022 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: IRB approval not received
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Papilloma, RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized crossover study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nita Sahani, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215249
- Sponsor's protocol ID
- 2019P001552
- Status last verified
- Jan 2022
- First submitted
- 21 Feb 2020
- Last updated
- 31 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transnasal Humidified High-Flow Oxygen Delivery (Optiflow) vs. Conventional Tubeless Anesthesia for the Prevention of Desaturations During Pediatric Laryngeal Papilloma Removal
- ClinicalTrials.gov ID
- NCT05215249
- Acronym / sponsor ID
- 2019P001552
- Conditions
- Laryngeal Papilloma, Recurrent
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB approval not received
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized crossover study
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Patient will receive conventional tubeless anesthesia |
| High Flow Oxygen Delivery | Experimental | Procedure: Transnasal humidified high-flow oxygen deliveryPatient will receive Transnasal humidified high-flow oxygen delivery (Optiflow) |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transnasal humidified high-flow oxygen deliveryAlso: OptiflowThe 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. | Procedure or surgery | High Flow Oxygen Delivery |
Primary outcome
Primary Endpoint
Time frame: End of study
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transnasal humidified high-flow oxygen delivery in people with Laryngeal Papilloma, Recurrent, run by Massachusetts Eye and Ear Infirmary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.