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 has been completed.
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
ClinicalTrials.gov Identifier:
First received: December 18, 2007
Last updated: April 27, 2015
Last verified: April 2015
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 ]

Enrollment: 15
Study Start Date: August 2013
Study Completion Date: November 2014
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00576771

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

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: April 27, 2015
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 26, 2016