Optiflow vs. Convential Anesthesia During Pediatric Laryngeal Papilloma Removal

NCT05215249 | Withdrawn Phase 1

• 1 other identifier: 2019P001552
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Laryngeal Papilloma, Recurrent

Outcome Measures

Primary Outcomes (1)

• 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.

  End of study

Study Arms (2)

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)

Procedure: Transnasal humidified high-flow oxygen delivery

Interventions

Transnasal humidified high-flow oxygen delivery PROCEDURE

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.

Also known as: Optiflow

High Flow Oxygen Delivery

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

MeSH Terms

Conditions

Recurrent respiratory papillomatosis

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized crossover study

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: January 31, 2022
• Study Start: February 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2022

Record last verified: 2022-01