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

• Sponsor: Policlinico Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00568100
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 55
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Procedure: PSV and NAVA	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• 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
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Respiratory mechanics, gas exchange, work of breathing [5 minutes]

Secondary Outcome Measures

1. Comfort of breathing [5 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Stable COPD patients during non invasive mechanical ventilation

Exclusion Criteria:

• Haemodynamic instability

• Coma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Policlinico Hospital	Milano		Italy	20122

Sponsors and Collaborators

• Policlinico Hospital

Investigators

• Principal Investigator: Davide Chiumello, MD, Policlinico Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Davide Chiumello, MD, Policlinico Hospital
• ClinicalTrials.gov Identifier: NCT00568100
• Other Study ID Numbers: 2222
• First Posted: Dec 5, 2007
• Last Update Posted: Apr 28, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Davide Chiumello, MD, Policlinico Hospital: gas exchange; pressure support ventilation; respiratory mechanics; COPD; NAVA
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Apr 28, 2015