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Examining the Effects of Nasal High Flow Oxygen Therapy Compared to Non-invasive Ventilation in Health Volunteers
Sponsor: Unity Health Toronto
Summary
Respiratory failure is characterized by low levels of oxygen and high levels of carbon dioxide in the blood which causes difficulty breathing. The management of patients with respiratory failure aims at improving oxygenation and changing the effort required to breathe. Mechanical ventilation is a life-saving treatment but may be associated with a high mortality rate, prolonged stay in the intensive care unit (ICU), and infection. Oxygenation techniques to avoid mechanical ventilation include standard oxygen therapy, continuous positive pressure (CPAP), and high-flow nasal cannula oxygen therapy (HFNC). CPAP consists of delivering oxygen through a mask. As compared to standard oxygen therapy, CPAP can promote lung recruitment leading to improved oxygenation and the effect in work of breathing in patients with respiratory failure. Conversely, high-flow nasal cannula oxygen therapy (HFNC) delivers oxygen through nasal prongs. Oxygen is heated and humidified and can be delivered at different flows (from 10 - 60 L/min). As compared to standard oxygen therapy, HFNC can promote some lung recruitment leading to mofiy oxygenation and work of breathing. Therefore, the present study will have 2 phases: Phase 1:Comparison of the physiological effects of different flows of HFNC to CPAP in healthy volunteers. The investigators hypothesized that the physiological effects of HFNC in the nasopharynx are comparable to that of CPAP at 4 cm H2O. Phase 2: Comparison of the physiological effects of different nasal interfaces of HFNC (Standard cannula vs. Asymmetrical cannula vs. Single-nostril adapted cannula) in healthy volunteers. The investigators hypothesized that the physiological effects of HFNC in the nasopharynx are comparable to that of CPAP at 4 cm H2O. It was hypothesized that asymmetrical which is the cannula that has a higher cross-sectional area generates higher nasal pharyngeal pressure.
Official title: Comparative Study of the Physiological Effects of High Flow Nasal Cannula and Non-invasive Ventilation in Healthy Volunteers
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
20
Start Date
2019-04-10
Completion Date
2026-10-01
Last Updated
2026-09-24
Healthy Volunteers
Yes
Conditions
Interventions
Phase 1 and 2
First, participant will be randomized to a protocol during our study. Participant will breathe normally at different flows of HFNC (20, 40 or 60 L/min) with their mouth open and mouth closed at each flow. They will breathe normally with CPAP at a positive pressure of 4 cm H2O. A lubricated catheter is inserted above the glottis through the nostril to measure ventilatory parameters. EIT is applied to measure inflation of the lung using electromagnetic waves that are not perceptible and are harmless. An ultrasound is done to measure the thickening of your diaphragm and of your abdominal muscles during inspiration and expiration and vocal cords position with and without HFNC (single measurement - around 3 min).During the second step, second catheter is inserted through the nostril to measure esophageal pressure. They will breathe for one additional minute during the closed mouth portions of the experiment while watching the esophageal pressure to ensure steady effort.
Phase 3
In the 3rd phase, according to randomization, volunteers will be masked with either RT041, RT043 or ONIV117 first, followed by the second mask then third mask, also randomize mouth position set to open or closed. The fitting of the masks will be determined based on the manufacturer guidelines and healthy volunteer tolerance. The mask will be adjusted to minimize leaks. At each step, EIT measurements will be recorded at regular breathing over a 10-minute period with an 8-minute washout between devices and 5-minute washout period between mouth positions. The transcutaneous CO2 will be continuously monitored from the earlobe throughout the protocol.
Locations (1)
St. Michael's Hospital
Toronto, Ontario, Canada