High-flow Nasal Cannula Nebulization of Beta 2 Adrenergic Agonist During Acute Exacerbation of Chronic Obstructive Pulmonary Disease
OPTINEB
1 other identifier
interventional
25
1 country
1
Brief Summary
High-flow nasal cannula is an oxygenation technique increasingly used for patients admitted for acute respiratory failure. Literature essentially concerns "de novo" acute hypoxemic failure and the interest of high-flow during take care of chronic obstructive pulmonary disease patients is few studied. Physiological studies reported potential benefits of high-flow nasal cannula oxygenation in chronic obstructive pulmonary disease patients including dead space clearance and decrease of respiratory, which lead to decrease work of breathing. As inhaled bronchodilators are part of treatment of chronic obstructive pulmonary disease exacerbation, nebulization could be also provided through high-flow nasal cannula oxygen therapy. The aim of our study is to determine whether a beta-2 agonist nebulization administered through High-flow nasal cannula is efficient to improve spirometry of patients for admitted hronic obstructive pulmonary disease exacerbation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 chronic-obstructive-pulmonary-disease
Started Jan 2019
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
January 12, 2018
CompletedFirst Posted
Study publicly available on registry
February 28, 2018
CompletedStudy Start
First participant enrolled
January 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedFebruary 12, 2019
February 1, 2019
12 months
January 12, 2018
February 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
compare lung functions
Evolution of Forced Expiratory Volume 1s
baseline-1h30
Study Arms (1)
TREATMENT
EXPERIMENTALsalbutamol nebulization
Interventions
Eligibility Criteria
You may qualify if:
- Arterial pH over 7.25,
- Respiratory rate under 35 breaths/mn
- Glasgow Coma Scale equal to 15,
- indication of beta-2 agonist nebulization less than 8 per day (time between two nebulization more than 3 hours),
- NIV sessions spaced more than 6 hours.
You may not qualify if:
- Urgent endotracheal intubation;
- Contraindication to beta 2 adrenergic agonist;
- Another organ failure (hemodynamic and neurological instability);
- Cardioselective beta-blocker during treatment of copd exacerbation;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
C.H.U. de Poitiers
Poitiers, 86000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2018
First Posted
February 28, 2018
Study Start
January 11, 2019
Primary Completion
January 1, 2020
Study Completion
April 1, 2020
Last Updated
February 12, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share