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Effect of Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist (NAVA) in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00568100
First Posted: December 5, 2007
Last Update Posted: April 28, 2015
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.
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
  Purpose
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.

Condition Intervention
Chronic Obstructive Pulmonary Disease Procedure: PSV and NAVA

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist (NAVA) in COPD Patients

Resource links provided by NLM:


Further study details as provided by Davide Chiumello, Policlinico Hospital:

Primary Outcome Measures:
  • Respiratory mechanics, gas exchange, work of breathing [ Time Frame: 5 minutes ]

Secondary Outcome Measures:
  • Comfort of breathing [ Time Frame: 5 minutes ]

Enrollment: 15
Study Start Date: April 2010
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
COPD patients
Procedure: PSV and NAVA
evaluated the effect of PSV and NAVA on breathing pattern, respiratory effort, gas exchange and level of breathing comfort 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable COPD patients during non invasive mechanical ventilation

Exclusion Criteria:

  • Haemodynamic instability
  • Coma
  Contacts and Locations
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): NCT00568100


Locations
Italy
Policlinico Hospital
Milano, Italy, 20122
Sponsors and Collaborators
Policlinico Hospital
Investigators
Principal Investigator: Davide Chiumello, MD Policlinico Hospital
  More Information

Responsible Party: Davide Chiumello, MD, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT00568100     History of Changes
Other Study ID Numbers: 2222
First Submitted: December 4, 2007
First Posted: December 5, 2007
Last Update Posted: April 28, 2015
Last Verified: April 2015

Keywords provided by Davide Chiumello, Policlinico Hospital:
gas exchange
pressure support ventilation
respiratory mechanics
COPD
NAVA

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases