Proportional Assist Ventilation (PAV) in Early Stage of Critically Ill Patients

November 23, 2012 updated by: Rafael Fernandez, Althaia Xarxa Assistencial Universitària de Manresa

High-assistance Proportional Assist Ventilation (PAV) vs. Assist-Control Ventilation (ACV) in Early Stage of Critically Ill Patients

To evaluate the effectiveness of high assistance proportional assist ventilation (PAV+) (objective 80% gain) as main ventilatory support in early stage of critically ill patients in comparison with standard volume-assist control ventilation (ACV).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this proposal is to apply PAV+ as routine ventilatory mode in the early stage of critically ill patients, taking advantages of spontaneous breathing and better patient-ventilator interaction.

The standard treatment in patients with acute respiratory failure is mechanical ventilation in control-mode for the first days of acute illness. This procedure is usually associated with patient-ventilator dyssynchrony, higher needs of sedation and/or relaxation, muscle atrophy, etc. PAV + is a new ventilatory mode that applies pressure in proportion to spontaneous patient inspiratory effort allowing better adaptation to changes in internal homeostasis.

Up to now, several reports compare PAV with assisted modes as a feasible alternative only in the weaning phase. However, PAV is able to unload patient effort in different levels, suggesting that high-assistance PAV (about 80%) could be comparable with assist-control modes in terms of respiratory muscles unload.

Whether PAV is as effective as traditional ACV in terms of ventilation muscle unload in the acute phase of illness has not been established and we aim to address this question.

We plan to prospectively enroll patients on mechanical ventilation early at ICU admission, and to ventilate them randomly under ACV (volume-assist control ventilation) or PAV+ (beginning with 80% if possible). We will evaluate length of mechanical ventilation, sedation requirements and respiratory-hemodynamic variables from the very beginning and until attending clinicians decide that patients are ready to be weaned.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 4

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

  • Spain
    • Catalunya
      • Manresa, Catalunya, Spain, 08243
        • Intensive Care Unit. Xarxa assistencial Althaia.

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 18 years of age or older
  • Anticipated MV > 24 hours
  • Availability of informed consent from patient or next of kin
  • Ventilation parameters measured under PAV+ 80% gain:

PaO2/FiO2 >100 RPAV <10 cm H2O/l/s CPAV > 30 ml/cm H2O WOBTOT <1.5 J/l VE <18 l/min

Exclusion Criteria:

  • Patients on moribund state or with life-sustaining therapy withholding decision.
  • Patients with unstable respiratory/hemodynamic state, PaO2/FiO2 <100, Dopamine >15 microg/Kg/min or epinephrine >0.1 microg/kg/min.
  • Pregnancy.
  • Air leak.
  • Patients needing deep sedation or muscle paralysis
  • Patients needing hyperventilation (brain trauma).
  • Patients with severe muscle weakness.
  • Recruitment maneuvers or prone position.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High assistance PAV+
Ventilatory support performed by PAV at 80% assistance (PB 840-plus) FiO2 and PEEP according to routine practice
Other: Mechanical ventilation mode (PAV+ vs. ACV)
Compare two ventilatory modes in the acute phase of illness
Other Names:
  • Proportional Assist ventilation (PAV+)
  • Assist Control ventilation
  • Critically ill patients
  • Mechanical ventilation
Active Comparator: Assist-control ventilation
Tidal volume, FiO2 and PEEP set according to routine practice
Other: Mechanical ventilation mode (PAV+ vs. ACV)
Compare two ventilatory modes in the acute phase of illness
Other Names:
  • Proportional Assist ventilation (PAV+)
  • Assist Control ventilation
  • Critically ill patients
  • Mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of mechanical ventilation
Time Frame: 28 days
Reduction of mechanical ventilation days when ventilated with high assistance PAV+ compared with ACV.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-inferiority of PAV+ compared to ACV in terms of gas exchange
Time Frame: 28 days
Non-inferiority of high assistance PAV+ compared to ACV in terms of gas exchange
28 days
Noninferiority of PAV in short term complications
Time Frame: 28 days
Similar incidence in the complications composite outcome (barotrauma, ARDS, atelectasis and pneumonia)
28 days
Noninferiority of PAV in weaning success
Time Frame: 28 days
Similar rate of weaning success defined as the composite end-point: time to resume spontaneous ventilation, rate of extubation success, need for non invasive ventilation (NIV) as rescue therapy, and reintubation rate.
28 days

Collaborators and Investigators

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

Sponsor

Althaia Xarxa Assistencial Universitària de Manresa

Collaborators

Medtronic - MITG

Investigators

  • Principal Investigator: Rafael Fernandez, M.D., Althaia Xarxa Assistencial Universitària de Manresa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

September 16, 2010

First Posted (Estimate)

September 17, 2010

Study Record Updates

Last Update Posted (Estimate)

November 27, 2012

Last Update Submitted That Met QC Criteria

November 23, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC 10-48

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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