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Effect of Increased Muscular Work During Different Weaning Strategies in Critically Ill Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Università degli Studi dell'Insubria.
Recruitment status was:  Recruiting
Information provided by:
Università degli Studi dell'Insubria Identifier:
First received: October 2, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted

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.

Condition Intervention
Acute Respiratory Failure Device: BIPAP Device: PSV Device: PSV + CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Università degli Studi dell'Insubria:

Primary Outcome Measures:
  • 1. Days of intubation 2. Days of mechanical ventilation [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • 1. The day of eventual tracheostomy 2. Organ Failure 3. The mortality at 28° day 4. Outcome at 6 months [ Time Frame: 1 year ]

Study Start Date: February 2005
Arms Assigned Interventions
Experimental: 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%)
Device: BIPAP
Experimental: 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.
Device: PSV
Experimental: 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.
Device: PSV + CPAP


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  1. Age higher than 18 yrs
  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:

  1. presence of chronic neuromuscular diseases
  2. need of surgical intervention within the next 72 hours
  3. difficult tracheal intubation
  4. tracheostomized patients
  Contacts and Locations
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Please refer to this study by its identifier: NCT00538746

Contact: Paolo Pelosi, Professor 0039-0332-278801

Ospedale di Circolo e Fondazione Macchi Recruiting
Varese, Italy, 21100
Contact: Paolo Pelosi, Professor    0039-0332-278801   
Principal Investigator: Paolo Pelosi, Professor         
Sponsors and Collaborators
Università degli Studi dell'Insubria
Principal Investigator: Paolo Pelosi, Professor Universita' degli Studi dell'Insubria
  More Information Identifier: NCT00538746     History of Changes
Other Study ID Numbers: 1500
Study First Received: October 2, 2007
Last Updated: October 2, 2007

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases processed this record on September 21, 2017