Clinical trial NCT01204281: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Failure
Mechanical Ventilation
Keywords: Proportional Assist Ventilation plus
Acute respiratory failure
Mechanical ventilation
Lead sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2010-09-17
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Length of mechanical ventilation
timeFrame: 28 days
Secondary outcomes:
measure: Non-inferiority of PAV+ compared to ACV in terms of gas exchange
timeFrame: 28 days
measure: Noninferiority of PAV in short term complications
timeFrame: 28 days
measure: Noninferiority of PAV in weaning success
timeFrame: 28 days
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Intensive Care Unit. Xarxa assistencial Althaia.
state: Catalunya
Study officials:
affiliation: Althaia Xarxa Assistencial Universitària de Manresa
name: Rafael Fernandez, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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
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.
citation: Younes M. Proportional-assist ventilation. In: Tobin MJ, editor. Principles and practice of mechanical ventilation. Illinois: McGraw-Hill; 2006. p. 335-64.