Recruiting

Nasal High Flow Oxygen Therapy vs. Non-invasive Ventilation

Sponsor:

Unity Health Toronto

Code:

NCT03902639

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Healthy Volunteers

Study ID

NCT03902639

Start date

Apr 10, 2019

Status verified date

Feb, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy volunteers ≥ 18 y-o,
  • No evidence of acute or chronic cardiopulmonary disease

Exclusion Criteria:

  • Active epistaxis, sinus problem, nasal trauma, or deviated septum that would preclude the nasopharyngeal catheter insertion,
  • Pregnancy, clinical evidence of respiratory illness, history of respiratory disease, body mass of over 50 kg/m2, ribcage malformation,
  • Cardiac pace maker or implantable cardioverter-defibrillator according to EIT manufacturer,
  • Allergy to topical lidocaine,
  • Claustrophobia that would preclude the use of CPAP or HFNC.

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • End expiratory nasopharyngeal pressure (NP) [ Time Frame: 5 minutes ]
  • End expiratory nasopharyngeal pressure (NP) [ Time Frame: 5min ]

Central Contacts and Locations

Central contacts

Laurent Brochard, MD

416-864-5686BrochardL@smh.ca

Frank Silva Bezerra, PhD

416-864-6060SilvaBezerrF@smh.ca

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B1T8

Contacts

Laurent Brochard, MD

416-864-6060BrochardL@smh.ca

More Information

Sponsor

Unity Health Toronto

Last update posted

Feb 20, 2024

Last verified

Feb, 2024

Keywords

  • High flow nasal cannula
  • Airway pressure
  • Lung volume
  • Non-invasive ventilation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2024-02-20.