Clinical trial NCT05215249: 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
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Laryngeal Papilloma, Recurrent
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized crossover study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Endpoint
timeFrame: End of study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: