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Completed

NCT Number: NCT01204281

Proportional Assist Ventilation (PAV) 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).

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Intensive Care Unit. Xarxa assistencial Althaia.

Manresa, Catalonia, 08243, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mechanical ventilation mode (PAV+ vs. ACV)

Other

Compare two ventilatory modes in the acute phase of illness

Other names: Proportional Assist ventilation (PAV+), Assist Control ventilation, Critically ill patients, Mechanical ventilation

Primary outcomes

  1. Length of mechanical ventilation

    Time frame: 28 days

    Reduction of mechanical ventilation days when ventilated with high assistance PAV+ compared with ACV.

Secondary outcomes

  1. 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

  2. Noninferiority of PAV in short term complications

    Time frame: 28 days

    Similar incidence in the complications composite outcome (barotrauma, ARDS, atelectasis and pneumonia)

  3. 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.

Sponsors and collaborators

Lead sponsor

Althaia Xarxa Assistencial Universitària de Manresa

Other

Collaborators

  • Medtronic - MITG

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 17, 2010
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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