Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Healthy Subjects
HDWOBSS
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 4, 2015
CompletedFirst Posted
Study publicly available on registry
July 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedJuly 13, 2015
July 1, 2015
4 months
June 4, 2015
July 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Work of breathing
Work of breathing at the end of each period is calculated from the measurement of esophageal pressure and tidal volume (composite outcome).
10 minutes
Secondary Outcomes (9)
Esophageal pressure-time product
10 minutes
Tidal Volume
10 minutes
Comfort of breathing
10 minutes
Blood gases
10 minutes
Dyspnea
10 minutes
- +4 more secondary outcomes
Study Arms (5)
No flow
NO INTERVENTIONSubjects will be spontaneously breathing in room air with no flow.
Conventional flow via nasal prongs
EXPERIMENTALSubjects will be breathing with nasal prongs delivering 5 L/min of air (inspired fraction of oxygen: 0.21)
High flow nasal cannulas 20 L/min
EXPERIMENTALSubjects will be breathing with high flow nasal cannulas delivering 20 L/min with an inspired fraction of oxygen of 0.21.
High flow nasal cannulas 40 L/min
EXPERIMENTALSubjects will be breathing with high flow nasal cannulas delivering 40 L/min with an inspired fraction of oxygen of 0.21.
High flow nasal cannulas 60 L/min
EXPERIMENTALSubjects will be breathing with high flow nasal cannulas delivering 60 L/min with an inspired fraction of oxygen of 0.21.
Interventions
Comparison of different flow levels
Low flow of air delivered through conventional nasal prongs
Eligibility Criteria
You may qualify if:
- Healthy subjects
- Written and informed consent
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
Study Sites (1)
Centre de Recherche de l'IUCPQ
Québec, Quebec, G1V4G5, Canada
Related Publications (1)
Delorme M, Bouchard PA, Simon M, Simard S, Lellouche F. Physiologic Effects of High-Flow Nasal Cannula in Healthy Subjects. Respir Care. 2020 Sep;65(9):1346-1354. doi: 10.4187/respcare.07306. Epub 2020 Apr 14.
PMID: 32291309DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
François Lellouche, MD, PhD
Fondation IUCPQ
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2015
First Posted
July 13, 2015
Study Start
June 1, 2015
Primary Completion
October 1, 2015
Last Updated
July 13, 2015
Record last verified: 2015-07