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.
Verified May 2013 by Policlinico Hospital
Sponsor:
Policlinico Hospital
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT00576771
First received: December 18, 2007
Last updated: May 15, 2013
Last verified: May 2013
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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 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 |
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.
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 | Not yet recruiting |
| Milan, Italy, 20122 | |
| Contact: Davide Chiumello, MD +39-0255033237 chiumello@libero.it | |
Sponsors and Collaborators
Policlinico Hospital
Investigators
| 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 |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |
ClinicalTrials.gov processed this record on June 18, 2013