Effect of Increased Muscular Work During Different Weaning Strategies in Critically Ill Patients
NCT ID: NCT00538746
Last Updated: 2007-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
INTERVENTIONAL
2005-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
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%)
BIPAP
2
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.
PSV
3
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.
PSV + CPAP
Interventions
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BIPAP
PSV
PSV + CPAP
Eligibility Criteria
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Inclusion Criteria
2. PaO2/FiO2 greater or equal than 150 with PEEP equal or lower than 10, and minute ventilation lower than 15 l/min
3. Temperature lower than 38,5°C
4. Stable hemodynamics: HR 60-125 b/min, SBP 90-160 mmHg without or with dopamine lower than 10 gamma/Kg/min or dobutamine lower than 10 gamma/Kg/min, no acute arrythmias
5. Hb higher than 8 g/dl
6. GCS higher or equal than 9
7. The attending physician has to agree that the patient is in stable conditions and ready to be weaned from the ventilator
Exclusion Criteria
2. need of surgical intervention within the next 72 hours
3. difficult tracheal intubation
4. tracheostomized patients
18 Years
ALL
No
Sponsors
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Università degli Studi dell'Insubria
OTHER
Principal Investigators
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Paolo Pelosi, Professor
Role: PRINCIPAL_INVESTIGATOR
Universita' degli Studi dell'Insubria
Locations
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Ospedale di Circolo e Fondazione Macchi
Varese, Varese, Italy
Countries
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Central Contacts
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Facility Contacts
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Paolo Pelosi, Professor
Role: primary
Other Identifiers
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1500
Identifier Type: -
Identifier Source: org_study_id