Effects of Different Assisted Mechanical Ventilation in ALI/ARDS Patients: PSV, NAVA and Controlled by Patient

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:	NCT00576771

Purpose

The investigators aim is to study the effect of pressure support ventilation versus neurally adjusted assist (NAVA) and controlled by patient in mechanically ventilated ALI/ARDS subjects.

Condition	Intervention
ALI/ARDS Patients	Procedure: PSV, NAVA, assisted controlled MV through a button

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Effects of Different Assisted Mechanical Ventilation in ALI/ARDS Patients: PSV, NAVA and Controlled by Patient

Further study details as provided by Policlinico Hospital:

Primary Outcome Measures:

Respiratory mechanics work of breathing,end expiratory lung volume, gas exchange, dead space, patient's comfort level [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
1: Experimental ALI/ARDS patients	Procedure: PSV, NAVA, assisted controlled MV through a button evaluated the effect of PSV, NAVA and assisted controlled mechanical ventilation by patient through a button

Detailed Description:

In this study, PSV is compared with NAVA and assisted mechanically ventilation controlled by patient through a button. Inclusion criteria are: assisted mechanically ventilated ALI/ARDS patients.

Eligibility

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

Criteria

Inclusion Criteria:

ALI/ARDS patients

Exclusion Criteria:

Haemodynamic instability
Barotrauma
COPD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576771

Contacts

Contact: Davide Chiumello, MD

+39-0255033237

chiumello@libero.it

Locations

Italy
Policlinico Hospital
Milan, 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:	222222
Study First Received:	December 18, 2007
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00576771
Health Authority:	Italy: Ministry of Health

ClinicalTrials.gov processed this record on January 16, 2009