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

Not Applicable

• Conditions: Acute Respiratory Failure
• Interventions: Device: PSV; Device: PSV + CPAP; Device: BIPAP

• Registration Number: NCT00538746
• Lead Sponsor: Università degli Studi dell'Insubria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Status Verified: 2007-10
• Study First Submitted: 2007-10-02
• Study First Submitted QC: 2007-10-02
• Last Update Submitted: 2007-10-02
• Study First Posted: 2007-10-03
• Last Update Posted: 2007-10-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	PSV	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	PSV + CPAP	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.
1	BIPAP	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%)

Primary Outcome Measures

Name	Time	Method
1. Days of intubation 2. Days of mechanical ventilation	28 days

Secondary Outcome Measures

Name	Time	Method
1. The day of eventual tracheostomy 2. Organ Failure 3. The mortality at 28° day 4. Outcome at 6 months	1 year

Trial Locations

Locations (1)

Ospedale di Circolo e Fondazione Macchi; 🇮🇹 Varese, Italy