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

This study is not yet open for participant recruitment.

Verified by Policlinico Hospital, September 2008

Sponsored by:	Policlinico Hospital
Information provided by:	Policlinico Hospital
ClinicalTrials.gov Identifier:	NCT00568100

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

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Gas

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Effect of Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist (NAVA) in COPD Patients

Further study details as provided by Policlinico Hospital:

Primary Outcome Measures:

Respiratory mechanics, gas exchange, work of breathing [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comfort of breathing [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	December 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stable COPD patients during non invasive mechanical ventilation

Exclusion Criteria:

Haemodynamic instability
Coma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568100

Contacts

Contact: Davide Chiumello, MD

+39-0255033237

chiumello@libero.it

Locations

Italy
Policlinico Hospital
Milano, Italy, 20122

Sponsors and Collaborators

Policlinico Hospital

Investigators

Principal Investigator:

Davide Chiumello, MD

Policlinico Hospital

More Information

Responsible Party:	Policlinico Hospital ( Davide Chiumello, MD )
Study ID Numbers:	2222
Study First Received:	December 4, 2007
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00568100
Health Authority:	Italy: Ministry of Health

Keywords provided by Policlinico Hospital:

gas exchange
pressure support ventilation
respiratory mechanics
COPD
NAVA

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 15, 2009