A Phase 4 interventional study of Mechanical ventilation mode (PAV+ vs. ACV) in Respiratory Failure and Mechanical Ventilation, sponsored by Althaia Xarxa Assistencial Universitària de Manresa. Completed at 1 site in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2012-11-27.
Sponsored by Althaia Xarxa Assistencial Universitària de Manresa · Phase 4, Interventional, and Treatment
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).
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 110 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Althaia Xarxa Assistencial Universitària de Manresa is the lead sponsor of 21 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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)
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
Also known as: Proportional Assist ventilation (PAV+), Assist Control ventilation, Critically ill patients, Mechanical ventilation
Length of mechanical ventilation
Reduction of mechanical ventilation days when ventilated with high assistance PAV+ compared with ACV.
Time frame: 28 days
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
Time frame: 28 days
Noninferiority of PAV in short term complications
Similar incidence in the complications composite outcome (barotrauma, ARDS, atelectasis and pneumonia)
Time frame: 28 days
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.
Time frame: 28 days
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Althaia Xarxa Assistencial Universitària de Manresa