NCT00576771

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
5.6 years until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

December 18, 2007

Last Update Submit

April 27, 2015

Conditions

ALI/ARDS Patients

Outcome Measures

Primary Outcomes (1)

  • Respiratory mechanics work of breathing,end expiratory lung volume, gas exchange, dead space, patient's comfort level

    30 minutes

Study Arms (1)

1

EXPERIMENTAL

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

Procedure: PSVProcedure: NAVAProcedure: patient-controlled

Interventions

PSVPROCEDURE

Pressure Support Ventilation

1
NAVAPROCEDURE

Neurally Adjusted Ventilatory Assist

1
patient-controlledPROCEDURE

assisted controlled MV through a button

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ALI/ARDS patients

You may not qualify if:

  • Haemodynamic instability
  • Barotrauma
  • COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Hospital

Milan, 20122, Italy

Location

MeSH Terms

Interventions

Analgesia, Patient-Controlled

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Officials

  • Davide Chiumello, MD

    Policlinico Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 19, 2007

Study Start

August 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

IT(1)