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

Primary Purpose

Respiratory Failure, Mechanical Ventilation

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Mechanical ventilation mode (PAV+ vs. ACV)
Sponsored by
Althaia Xarxa Assistencial Universitària de Manresa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Proportional Assist Ventilation plus, Acute respiratory failure, Mechanical ventilation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Intensive Care Unit. Xarxa assistencial Althaia.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High assistance PAV+

Assist-control ventilation

Arm Description

Ventilatory support performed by PAV at 80% assistance (PB 840-plus) FiO2 and PEEP according to routine practice

Tidal volume, FiO2 and PEEP set according to routine practice

Outcomes

Primary Outcome Measures

Length of mechanical ventilation
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
Non-inferiority of high assistance PAV+ compared to ACV in terms of gas exchange
Noninferiority of PAV in short term complications
Similar incidence in the complications composite outcome (barotrauma, ARDS, atelectasis and pneumonia)
Noninferiority of PAV in weaning success
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.

Full Information

First Posted
September 15, 2010
Last Updated
November 23, 2012
Sponsor
Althaia Xarxa Assistencial Universitària de Manresa
Collaborators
Medtronic - MITG
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1. Study Identification

Unique Protocol Identification Number
NCT01204281
Brief Title
Proportional Assist Ventilation (PAV) in Early Stage of Critically Ill Patients
Official Title
High-assistance Proportional Assist Ventilation (PAV) vs. Assist-Control Ventilation (ACV) in Early Stage of Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Althaia Xarxa Assistencial Universitària de Manresa
Collaborators
Medtronic - MITG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Mechanical Ventilation
Keywords
Proportional Assist Ventilation plus, Acute respiratory failure, Mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High assistance PAV+
Arm Type
Experimental
Arm Description
Ventilatory support performed by PAV at 80% assistance (PB 840-plus) FiO2 and PEEP according to routine practice
Arm Title
Assist-control ventilation
Arm Type
Active Comparator
Arm Description
Tidal volume, FiO2 and PEEP set according to routine practice
Intervention Type
Other
Intervention Name(s)
Mechanical ventilation mode (PAV+ vs. ACV)
Other Intervention Name(s)
Proportional Assist ventilation (PAV+), Assist Control ventilation, Critically ill patients, Mechanical ventilation
Intervention Description
Compare two ventilatory modes in the acute phase of illness
Primary Outcome Measure Information:
Title
Length of mechanical ventilation
Description
Reduction of mechanical ventilation days when ventilated with high assistance PAV+ compared with ACV.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Non-inferiority of PAV+ compared to ACV in terms of gas exchange
Description
Non-inferiority of high assistance PAV+ compared to ACV in terms of gas exchange
Time Frame
28 days
Title
Noninferiority of PAV in short term complications
Description
Similar incidence in the complications composite outcome (barotrauma, ARDS, atelectasis and pneumonia)
Time Frame
28 days
Title
Noninferiority of PAV in weaning success
Description
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.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Fernandez, M.D.
Organizational Affiliation
Althaia Xarxa Assistencial Universitària de Manresa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive Care Unit. Xarxa assistencial Althaia.
City
Manresa
State/Province
Catalunya
ZIP/Postal Code
08243
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
10712328
Citation
Grasso S, Puntillo F, Mascia L, Ancona G, Fiore T, Bruno F, Slutsky AS, Ranieri VM. Compensation for increase in respiratory workload during mechanical ventilation. Pressure-support versus proportional-assist ventilation. Am J Respir Crit Care Med. 2000 Mar;161(3 Pt 1):819-26. doi: 10.1164/ajrccm.161.3.9902065.
Results Reference
result
Citation
Georgopoulos, D., Plataki, M., Prinianakis, G., Kondili, E., Current status of proportional assist ventilation. International journal of Intensive Care, 2007. Autumn: p. 19-26.
Results Reference
result
Citation
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
Results Reference
result
PubMed Identifier
16394778
Citation
Putensen C, Muders T, Varelmann D, Wrigge H. The impact of spontaneous breathing during mechanical ventilation. Curr Opin Crit Care. 2006 Feb;12(1):13-8. doi: 10.1097/01.ccx.0000198994.37319.60.
Results Reference
result
Citation
Younes M. Proportional-assist ventilation. In: Tobin MJ, editor. Principles and practice of mechanical ventilation. Illinois: McGraw-Hill; 2006. p. 335-64.
Results Reference
result

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

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