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

NCT ID: NCT01204281

Last Updated: 2012-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-09-30

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.

Conditions

Respiratory Failure; Mechanical Ventilation

Keywords

Proportional Assist Ventilation plus; Acute respiratory failure; Mechanical ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High assistance PAV+

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

Group Type: EXPERIMENTAL

Mechanical ventilation mode (PAV+ vs. ACV)

Intervention Type: OTHER

Compare two ventilatory modes in the acute phase of illness

Assist-control ventilation

Tidal volume, FiO2 and PEEP set according to routine practice

Group Type: ACTIVE_COMPARATOR

Mechanical ventilation mode (PAV+ vs. ACV)

Intervention Type: OTHER

Compare two ventilatory modes in the acute phase of illness

Interventions

Mechanical ventilation mode (PAV+ vs. ACV)

Compare two ventilatory modes in the acute phase of illness

Intervention Type: OTHER

Other Intervention Names

Proportional Assist ventilation (PAV+); Assist Control ventilation; Critically ill patients; Mechanical ventilation

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: collaborator

Althaia Xarxa Assistencial Universitària de Manresa

OTHER

Sponsor Role: lead

Responsible Party

Rafael Fernandez

Head of Intensive Care Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rafael Fernandez, M.D.

Role: PRINCIPAL_INVESTIGATOR

Althaia Xarxa Assistencial Universitària de Manresa

Locations

Intensive Care Unit. Xarxa assistencial Althaia.

Manresa, Catalonia, Spain

Countries

Spain

References

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.

Reference Type: RESULT

PMID: 10712328 (View on PubMed)

Georgopoulos, D., Plataki, M., Prinianakis, G., Kondili, E., Current status of proportional assist ventilation. International journal of Intensive Care, 2007. Autumn: p. 19-26.

Reference Type: RESULT

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

Reference Type: RESULT

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.

Reference Type: RESULT

PMID: 16394778 (View on PubMed)

Younes M. Proportional-assist ventilation. In: Tobin MJ, editor. Principles and practice of mechanical ventilation. Illinois: McGraw-Hill; 2006. p. 335-64.

Reference Type: RESULT

Other Identifiers

CEIC 10-48

Identifier Type: -

Identifier Source: org_study_id