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

This study has been completed.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Rafael Fernandez, Fundació Althaia
ClinicalTrials.gov Identifier:
NCT01204281
First received: September 15, 2010
Last updated: November 23, 2012
Last verified: November 2012
  Purpose

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).


Condition Intervention Phase
Respiratory Failure
Mechanical Ventilation
Other: Mechanical ventilation mode (PAV+ vs. ACV)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: High-assistance Proportional Assist Ventilation (PAV) vs. Assist-Control Ventilation (ACV) in Early Stage of Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by Althaia Xarxa Assistencial Universitària de Manresa:

Primary Outcome Measures:
  • Length of mechanical ventilation [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Reduction of mechanical ventilation days when ventilated with high assistance PAV+ compared with ACV.


Secondary Outcome Measures:
  • Non-inferiority of PAV+ compared to ACV in terms of gas exchange [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Non-inferiority of high assistance PAV+ compared to ACV in terms of gas exchange

  • Noninferiority of PAV in short term complications [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Similar incidence in the complications composite outcome (barotrauma, ARDS, atelectasis and pneumonia)

  • Noninferiority of PAV in weaning success [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 110
Study Start Date: September 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204281

Locations
Spain
Intensive Care Unit. Xarxa assistencial Althaia.
Manresa, Catalunya, Spain, 08243
Sponsors and Collaborators
Althaia Xarxa Assistencial Universitària de Manresa
Covidien
Investigators
Principal Investigator: Rafael Fernandez, M.D. Althaia Xarxa Assistencial Universitària de Manresa
  More Information

Publications:
Georgopoulos, D., Plataki, M., Prinianakis, G., Kondili, E., Current status of proportional assist ventilation. International journal of Intensive Care, 2007. Autumn: p. 19-26.
Delgado M, Zavala E, Tomas R, Fernandez R. "Feasibility of proportional assist ventilation as routine ventilatory support in intensive care patients". Intensive Care Med 2009; 35; Suppl 1: S125
Younes M. Proportional-assist ventilation. In: Tobin MJ, editor. Principles and practice of mechanical ventilation. Illinois: McGraw-Hill; 2006. p. 335-64.

Responsible Party: Rafael Fernandez, Head of Intensive Care Department, Fundació Althaia
ClinicalTrials.gov Identifier: NCT01204281     History of Changes
Other Study ID Numbers: CEIC 10-48
Study First Received: September 15, 2010
Last Updated: November 23, 2012
Health Authority: Spain: Ethics Committee
Spain: Ministry of Health

Keywords provided by Althaia Xarxa Assistencial Universitària de Manresa:
Proportional Assist Ventilation plus
Acute respiratory failure
Mechanical ventilation

Additional relevant MeSH terms:
Critical Illness
Respiratory Insufficiency
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014