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

NCT00538746 | Unknown

• 1 other identifier: 1500
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• 1. Days of intubation 2. Days of mechanical ventilation

  28 days

Secondary Outcomes (1)

• 1. The day of eventual tracheostomy 2. Organ Failure 3. The mortality at 28° day 4. Outcome at 6 months

  1 year

Study Arms (3)

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%)

Device: BIPAP

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.

Device: PSV

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.

Device: PSV + CPAP

Interventions

BIPAP DEVICE

1

PSV DEVICE

2

PSV + CPAP DEVICE

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age higher than 18 yrs
• PaO2/FiO2 greater or equal than 150 with PEEP equal or lower than 10, and minute ventilation lower than 15 l/min
• Temperature lower than 38,5°C
• 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
• Hb higher than 8 g/dl
• GCS higher or equal than 9
• The attending physician has to agree that the patient is in stable conditions and ready to be weaned from the ventilator

You may not qualify if:

• presence of chronic neuromuscular diseases
• need of surgical intervention within the next 72 hours
• difficult tracheal intubation
• tracheostomized patients

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

Ospedale di Circolo e Fondazione Macchi

Varese, Varese, 21100, Italy

RECRUITING

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Paolo Pelosi, Professor

  Universita' degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Pelosi, Professor

CONTACT

0039-0332-278801; ppelosi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 2, 2007
• First Posted: October 3, 2007
• Study Start: February 1, 2005
• Last Updated: October 3, 2007

Record last verified: 2007-10

Locations

IT (1)