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

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ClinicalTrials.gov Identifier: NCT03902639
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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 decreasing the effort required to breathe. Mechanical ventilation is a life-saving treatment, but may be associated with a high mortality rate, increased length of intensive care unit (ICU) stay 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 decreased 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 improved oxygenation, and decreased work of breathing. Therefore, the present study will compare the physiological effects of different flows of HFNC to CPAP in healthy volunteers. The investigators hypothesize that the physiological effects of HFNC in the nasopharynx are comparable to that of CPAP at 4 cm H2O.

Condition or disease
Healthy Volunteers

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Study of the Physiological Effects of High Flow Nasal Cannula and Non-invasive Ventilation in Healthy Volunteers
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020



Primary Outcome Measures :
  1. End expiratory nasopharyngeal pressure (NP) [ Time Frame: 5 minutes ]
    The primary endpoint is to compare the end expiratory nasopharyngeal pressure (NP) under 60 L/min of high flow nasal cannula (HFNC) to continuous positive airway pressure (CPAP 4 cmH2O). This will be assessed using a nasopharyngeal catheter.


Secondary Outcome Measures :
  1. Change in physiologic variables of airway pressure at different flows of HFNC (20, 40, and 60 L/min) and CPAP (4 cmH20). [ Time Frame: 1 hour ]

    One of the secondary endpoints is to compare variables of airway pressure at different flows of HFNC to CPAP. We will measure the end expiratory NP, mean NP, mean peak inspiratory pressure, mean peak expiratory pressure, delta inspiratory pressure and delta expiratory pressure.

    Each of these variables will be measured for 1 minute using a nasopharyngeal catheter. Furthermore, at each flow of HFNC, we will ask the patient to breathe with their mouth open and mouth closed.


  2. Change in end-expiratory lung impedance [ Time Frame: 1 hour ]
    The other secondary endpoint is to compare the change in ventilation distribution and end-expiratory lung impedance at different flows of HFNC and CPAP. These variables will be measured using electrical impedance tomography (EIT) by placing a band around the chest of each participant.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers responding to advertisement posted through the St. Michael's Hospital Communications board.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902639


Contacts
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Contact: Laurent Brochard, MD 416-864-5686 ext 5686 BrochardL@smh.ca
Contact: Frank Silva Bezerra, PhD 416-864-6060 ext 6214 SilvaBezerrF@smh.ca

Locations
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Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B1T8
Contact: Laurent Brochard, MD    416-864-6060 ext 5686    BrochardL@smh.ca   
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Laurent Brochard, MD St. Michael's Hospital, Toronto
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03902639    
Other Study ID Numbers: REB# 19-006
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Michael's Hospital, Toronto:
High flow nasal cannual
Airway pressure
Lung volume
Non-invasive ventilation