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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT00568100
First received: December 4, 2007
Last updated: November 13, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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: April 2010
Estimated Study Completion Date: November 2014
Estimated 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Davide Chiumello, MD, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT00568100     History of Changes
Other Study ID Numbers: 2222
Study First Received: December 4, 2007
Last Updated: November 13, 2013
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 24, 2014