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

April 27, 2015 updated by: Davide Chiumello, Policlinico Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20122
        • Policlinico Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ALI/ARDS patients

Exclusion Criteria:

  • Haemodynamic instability
  • Barotrauma
  • COPD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Respiratory mechanics work of breathing,end expiratory lung volume, gas exchange, dead space, patient's comfort level
Time Frame: 30 minutes
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Policlinico Hospital

Investigators

  • Principal Investigator: davide chiumello, md, Policlinico Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

December 18, 2007

First Submitted That Met QC Criteria

December 18, 2007

First Posted (Estimate)

December 19, 2007

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 222222

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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