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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204281
• Other study ID #: CEIC 10-48
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2010
• Last updated: November 23, 2012
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: Althaia Xarxa Assistencial Universitària de Manresa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Mechanical Ventilation
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Mechanical ventilation mode (PAV+ vs. ACV)
Compare two ventilatory modes in the acute phase of illness

Locations

Country	Name	City	State
Spain	Intensive Care Unit. Xarxa assistencial Althaia.	Manresa	Catalunya

Sponsors (2)

Lead Sponsor	Collaborator
Althaia Xarxa Assistencial Universitària de Manresa	Medtronic - MITG

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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

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

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 M — View 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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of mechanical ventilation	Reduction of mechanical ventilation days when ventilated with high assistance PAV+ compared with ACV.	28 days	Yes
Secondary	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	28 days	Yes
Secondary	Noninferiority of PAV in short term complications	Similar incidence in the complications composite outcome (barotrauma, ARDS, atelectasis and pneumonia)	28 days	Yes
Secondary	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.	28 days	No