We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Healthy Subjects (HDWOBSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02495675
Recruitment Status : Unknown
Verified July 2015 by Laval University.
Recruitment status was:  Recruiting
First Posted : July 13, 2015
Last Update Posted : July 13, 2015
Sponsor:
Information provided by (Responsible Party):
Laval University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study evaluates the work of breathing among healthy subjects under various conditions of treatment with high flow nasal cannulas. Ten subjects will be included. The design of this study is a cross over of five treatment periods with different flow settings.

Condition or disease Intervention/treatment Phase
Respiratory Failure Device: High flow nasal cannulas Device: Conventional flow via nasal prongs Not Applicable

Detailed Description:

High flow oxygen therapy (HFOT) is a promising technique increasingly used in the management of acute respiratory failure. In hospitalised hypoxemic patients, recent clinical evidence showed that HFOT can reduce endotracheal intubation and reduce mortality. Physiologically, the HFOT causes a decrease in respiratory rate and minute-ventilation and may be associated with a decrease in carbone dioxyde arterial pressure. It is possible that these effects are associated with decreased work of breathing, which could explain some of the benefits in terms of comfort and efficiency.

The objective of this research is to evaluate the impact of a wash-out of anatomical dead space by high flow nasal cannulas on respiratory parameters and on the work of breathing among healthy subjects. The investigators will evaluate the baseline status in room air, and then compare it with four different levels of flow. The primary endpoint will be the work of breathing.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Healthy Subjects
Study Start Date : June 2015
Estimated Primary Completion Date : October 2015
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
No Intervention: No flow
Subjects will be spontaneously breathing in room air with no flow.
Experimental: Conventional flow via nasal prongs
Subjects will be breathing with nasal prongs delivering 5 L/min of air (inspired fraction of oxygen: 0.21)
 Device: Conventional flow via nasal prongs
Low flow of air delivered through conventional nasal prongs
Experimental: High flow nasal cannulas 20 L/min
Subjects will be breathing with high flow nasal cannulas delivering 20 L/min with an inspired fraction of oxygen of 0.21.
 Device: High flow nasal cannulas
Comparison of different flow levels
Other Name: Airvo 2; Ficher and Paykel HealthCare
Experimental: High flow nasal cannulas 40 L/min
Subjects will be breathing with high flow nasal cannulas delivering 40 L/min with an inspired fraction of oxygen of 0.21.
 Device: High flow nasal cannulas
Comparison of different flow levels
Other Name: Airvo 2; Ficher and Paykel HealthCare
Experimental: High flow nasal cannulas 60 L/min
Subjects will be breathing with high flow nasal cannulas delivering 60 L/min with an inspired fraction of oxygen of 0.21.
 Device: High flow nasal cannulas
Comparison of different flow levels
Other Name: Airvo 2; Ficher and Paykel HealthCare


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Work of breathing [ Time Frame: 10 minutes ]
    Work of breathing at the end of each period is calculated from the measurement of esophageal pressure and tidal volume (composite outcome).


Secondary Outcome Measures :
  1. Esophageal pressure-time product [ Time Frame: 10 minutes ]
    Measured at the end of each period

  2. Tidal Volume [ Time Frame: 10 minutes ]
    Measured at the end of each period

  3. Comfort of breathing [ Time Frame: 10 minutes ]
    Subjective evaluation at the end of each period

  4. Blood gases [ Time Frame: 10 minutes ]
    Arterial or capillary blood gases at the end of each period

  5. Dyspnea [ Time Frame: 10 minutes ]
    Evaluation on a borg scale at the end of each period

  6. Respiratory Rate [ Time Frame: 10 minutes ]
    Measured at the end of each period

  7. End-tidal carbon dioxide [ Time Frame: 10 minutes ]
    Measured at the end of each period

  8. Heart rate [ Time Frame: 10 minutes ]
    Measured at the end of each period

  9. Oxygen saturation [ Time Frame: 10 minutes ]
    Measured at the end of each period


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects
  • Written and informed consent

Exclusion Criteria:

  • Pregnant or breastfeeding women;
  • Subject enrolled in another study excluding co-enrolment;
  • Cardio-vascular or respiratory disease;
  • History of ear nose and throat disease (i.e. surgery, epistaxis, trauma), eso-gastric disease (i.e. esophageal varices, digestive haemorrhage), rheumatologic or neurologic disease possibly interfering with the design of the study;
  • Subject feeling nauseous or under recent fed condition (<1h).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02495675


Contacts
Layout table for location contacts
Contact: Mathieu Delorme, PT, MSc 418-656-8711 ext 3508 mathieu.delorme.2@ulaval.ca
Contact: François Lellouche, MD, PhD 418-656-8711 ext 3298 francois.lellouche@criucpq.ulaval.ca

Locations
Layout table for location information
Canada, Quebec
Centre de Recherche de l'IUCPQ Recruiting
Québec, Quebec, Canada, G1V4G5
Contact: François Lellouche, MD, PhD    418-656-8711 ext 3298    francois.lellouche@criucpq.ulaval.ca   
Sponsors and Collaborators
Laval University
Investigators
Layout table for investigator information
Study Director: François Lellouche, MD, PhD Fondation IUCPQ
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT02495675    
Other Study ID Numbers: IUCPQ-HDWOBSS
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: July 13, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases