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| Name | Class |
|---|---|
| Medtronic - MITG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High assistance PAV+ | Experimental | Ventilatory support performed by PAV at 80% assistance (PB 840-plus) FiO2 and PEEP according to routine practice |
|
| Assist-control ventilation | Active Comparator | Tidal volume, FiO2 and PEEP set according to routine practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical ventilation mode (PAV+ vs. ACV) | Other | Compare two ventilatory modes in the acute phase of illness |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of mechanical ventilation | Reduction of mechanical ventilation days when ventilated with high assistance PAV+ compared with ACV. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Noninferiority of PAV in short term complications |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Rafael Fernandez, M.D. | Althaia Xarxa Assistencial Università ria de Manresa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive Care Unit. Xarxa assistencial Althaia. | Manresa | Catalonia | 08243 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10712328 | Result | 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. | |
| Result | Georgopoulos, D., Plataki, M., Prinianakis, G., Kondili, E., Current status of proportional assist ventilation. International journal of Intensive Care, 2007. Autumn: p. 19-26. | ||
| 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 | ||
| 16394778 |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D059725 | Interactive Ventilatory Support |
| D012121 | Respiration, Artificial |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
| D012151 | Resuscitation |
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|
Similar incidence in the complications composite outcome (barotrauma, ARDS, atelectasis and pneumonia)
| 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. | 28 days |
| 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. |
| Result | Younes M. Proportional-assist ventilation. In: Tobin MJ, editor. Principles and practice of mechanical ventilation. Illinois: McGraw-Hill; 2006. p. 335-64. |
| D004638 |
| Emergency Treatment |