Examining the Effects of Nasal High Flow Oxygen Therapy Compared to Non-invasive Ventilation in Health Volunteers

NCT ID: NCT03902639

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-10
• Study Completion Date: 2024-12-31

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Brochard, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Laurent Brochard, MD

Role: CONTACT

BrochardL@smh.ca

416-864-5686 ext. 5686

Frank Silva Bezerra, PhD

Role: CONTACT

SilvaBezerrF@smh.ca

416-864-6060 ext. 6214

Facility Contacts

Laurent Brochard, MD

Role: primary

BrochardL@smh.ca

416-864-6060 ext. 5686

Other Identifiers

REB# 19-006

Identifier Type: -

Identifier Source: org_study_id