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Most patients admitted to intensive care units require mechanical ventilation. Weaning from assisted/controlled ventilation begins when we recognize that the patient has recovered adeguately from acute respiratory failure.
If weaning is delayed, costs are increased, as are the risks of nosocomial pneumonia, cardiac-associated morbility, and death. On the other hand, weaning too soon often results in reintubation, which is associated with complications similar to those of prolonged ventilation.
The aim of this trial is to establish an evidence-based approach to weaning and to determine when a patient is ready to be weaned from mechanical ventilation, and what is the best weaning technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | BIPAP (Bilevel Positive Airway Pressure) targeted on: TV 6-8 ml/kg, total RR 10-30/min, PEEP and FiO2 regulated on Sat greater than 92% (with spontaneous RR between 20-40%) |
|
| 2 | Experimental | PSV (pressure support ventilation) targeted on: TV 6-8 ml/kg,total RR 10-30/min, PEEP and FiO2 regulated on Sat greater than 92, a minimum of 7 cmH2O of PS is tolerated. |
|
| 3 | Experimental | PSV+CPAP (continuous positive airway pressure) targeted on: PSV: TV 6-8 ml/kg,total RR 10-30/min, PEEP and FiO2 regulated on Sat greater than 92, a minimum of 7 cmH2O of PS is tolerated, CPAP (5-10 cmH2O) at least 2 hours a day. If during the CPAP periods at least 1 of the criteria T tube test failure occurs, the patients will come back immediately to PSV. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIPAP | Device |
| ||
| PSV | Device |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Days of intubation 2. Days of mechanical ventilation | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 1. The day of eventual tracheostomy 2. Organ Failure 3. The mortality at 28° day 4. Outcome at 6 months | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paolo Pelosi, Professor | Contact | 0039-0332-278801 | ppelosi@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Paolo Pelosi, Professor | Universita' degli Studi dell'Insubria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale di Circolo e Fondazione Macchi | Recruiting | Varese | Varese | 21100 | Italy |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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|
| PSV + CPAP | Device |
|
| D012138 |
| Respiratory Therapy |