Intensive Care Unit. Xarxa assistencial Althaia.
Manresa, Catalonia, 08243, Spain
NCT Number: NCT01204281
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).
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Notify Me18 year–90 year
All sexes
Interventional
Phase 4
Manresa, Catalonia, 08243, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Compare two ventilatory modes in the acute phase of illness
Other names: Proportional Assist ventilation (PAV+), Assist Control ventilation, Critically ill patients, Mechanical ventilation
Time frame: 28 days
Reduction of mechanical ventilation days when ventilated with high assistance PAV+ compared with ACV.
Time frame: 28 days
Non-inferiority of high assistance PAV+ compared to ACV in terms of gas exchange
Time frame: 28 days
Similar incidence in the complications composite outcome (barotrauma, ARDS, atelectasis and pneumonia)
Time frame: 28 days
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.
Althaia Xarxa Assistencial Universitària de Manresa
Other
High-assistance Proportional Assist Ventilation (PAV) vs. Assist-Control Ventilation (ACV) in Early Stage of Critically Ill Patients
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