Back to resultsEffect of Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist (NAVA) in Chronic Obstructive Pulmonary Disease (COPD) Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PSV and NAVA
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring gas exchange, pressure support ventilation, respiratory mechanics, COPD, NAVA
Eligibility Criteria
Inclusion Criteria:
- Stable COPD patients during non invasive mechanical ventilation
Exclusion Criteria:
- Haemodynamic instability
- Coma
Sites / Locations
- Policlinico Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
COPD patients
Outcomes
Primary Outcome Measures
Respiratory mechanics, gas exchange, work of breathing
Secondary Outcome Measures
Comfort of breathing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00568100
Brief Title
Effect of Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist (NAVA) in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Effect of Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist (NAVA) in COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Policlinico Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators' aim is to study the effect of pressure support ventilation at two levels of PEEP and Pressure Support versus neurally adjusted ventilatory assist (NAVA) in COPD patients.
Detailed Description
In this study, two levels of pressure support and PEEP during pressure support ventilation are compared with neurally adjusted ventilatory assist (NAVA) in COPD patients by measuring respiratory mechanics, intrinsic PEEP, work of breathing and patient's level of comfort.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
gas exchange, pressure support ventilation, respiratory mechanics, COPD, NAVA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
COPD patients
Intervention Type
Procedure
Intervention Name(s)
PSV and NAVA
Intervention Description
evaluated the effect of PSV and NAVA on breathing pattern, respiratory effort, gas exchange and level of breathing comfort in COPD patients
Primary Outcome Measure Information:
Title
Respiratory mechanics, gas exchange, work of breathing
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Comfort of breathing
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stable COPD patients during non invasive mechanical ventilation
Exclusion Criteria:
Haemodynamic instability
Coma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davide Chiumello, MD
Organizational Affiliation
Policlinico Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Hospital
City
Milano
ZIP/Postal Code
20122
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Effect of Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist (NAVA) in Chronic Obstructive Pulmonary Disease (COPD) Patients
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