Effects of Different Assisted Mechanical Ventilation in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients: Pressure Support Ventilation (PSV), Neurally Adjusted Ventilatory Assist (NAVA) and Controlled by Patient

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Policlinico Hospital
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
ClinicalTrials.gov Identifier:
First received: December 18, 2007
Last updated: May 15, 2013
Last verified: May 2013

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
Procedure: NAVA
Procedure: patient-controlled

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Different Assisted Mechanical Ventilation in ALI/ARDS Patients: PSV, NAVA and Controlled by Patient

Resource links provided by NLM:

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: August 2013
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

ALI/ARDS patients

evaluated the effect of PSV, NAVA and assisted controlled mechanical ventilation by patient through a button

Procedure: PSV
Pressure Support Ventilation
Procedure: NAVA
Neurally Adjusted Ventilatory Assist
Procedure: patient-controlled
assisted controlled MV 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.


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

Inclusion Criteria:

  • ALI/ARDS patients

Exclusion Criteria:

  • Haemodynamic instability
  • Barotrauma
  • COPD
  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: NCT00576771

Contact: Davide Chiumello, MD +39-0255033237 chiumello@libero.it

Policlinico Hospital Not yet recruiting
Milan, Italy, 20122
Contact: Davide Chiumello, MD    +39-0255033237    chiumello@libero.it   
Sponsors and Collaborators
Policlinico Hospital
Principal Investigator: Davide Chiumello, MD Policlinico Hospital
  More Information

No publications provided

Responsible Party: Davide Chiumello, MD, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT00576771     History of Changes
Other Study ID Numbers: 222222
Study First Received: December 18, 2007
Last Updated: May 15, 2013
Health Authority: Italy: Ministry of Health

ClinicalTrials.gov processed this record on March 26, 2015