Short Term Physiological Effects of Nasal High Flow Oxygen on Respiratory Mechanics
1 other identifier
interventional
14
1 country
1
Brief Summary
Nasal High Oxygen Flow (HOF) has been demonstrated to reduce the re-intubation rate in hypoxic patients and ameliorate breathing pattern in hypercapnic patients. The aim of this study is to better understand the physiological mechanism underlying these results, assessing the respiratory mechanics in stable hypercapnic COPD patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2015
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
First Submitted
Initial submission to the registry
February 3, 2015
CompletedFirst Posted
Study publicly available on registry
February 16, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedOctober 11, 2016
October 1, 2016
1.5 years
February 3, 2015
October 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
recording of respiratory mechanics
Respiratory mechanics will be assessed using Mead and Wittenberger's technique.
30 minutes per arm
Secondary Outcomes (1)
dyspnea score
30 minutes per arm
Study Arms (4)
spontaneous breathing trial
PLACEBO COMPARATORthe patients will be asked to breathe spontaneously using their acutal low oxygen flow
HOF20
ACTIVE COMPARATORthe patients will be asked to breathe with HOF of 20 L/min
HOF30
ACTIVE COMPARATORthe patients will be asked to breathe with HOF of 30 L/min
noninvasive mechanical ventilation (NIV)
ACTIVE COMPARATORthe patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
Interventions
the addition of high oxygen flow to patients breathing spontaneously
the addition of a ventilatory support delivered with a oro-nasal interface
Eligibility Criteria
You may qualify if:
- COPD patients
- Chronic hypercapnic respiratory failure (pH\>7.34 and PaCO2\>45 mmHg)
You may not qualify if:
- Cancer
- Neurological and cardiac disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San'Orsola Malpighi Hospital, Bologna ITALY
Bologna, 40138, Italy
Related Publications (1)
Pisani L, Fasano L, Corcione N, Comellini V, Musti MA, Brandao M, Bottone D, Calderini E, Navalesi P, Nava S. Change in pulmonary mechanics and the effect on breathing pattern of high flow oxygen therapy in stable hypercapnic COPD. Thorax. 2017 Apr;72(4):373-375. doi: 10.1136/thoraxjnl-2016-209673. Epub 2017 Jan 19.
PMID: 28104830DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
stefano nava, md
Sant'Orsola Malpighi Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Respiratory and Critical care Unit
Study Record Dates
First Submitted
February 3, 2015
First Posted
February 16, 2015
Study Start
March 1, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
October 11, 2016
Record last verified: 2016-10