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

Acute Respiratory Failure Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00538746
• Other study ID #: 1500
• Status: Recruiting
• Phase: N/A
• First received: October 2, 2007
• Last updated: October 2, 2007
• Start date: February 2005

Study information

• Verified date: October 2007
• Source: Università degli Studi dell'Insubria
• Contact: Paolo Pelosi, Professor
• Phone: 0039-0332-278801
• Email: ppelosi[@]hotmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• BIPAP

• PSV

• PSV + CPAP

Locations

Country	Name	City	State
Italy	Ospedale di Circolo e Fondazione Macchi	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Days of intubation 2. Days of mechanical ventilation		28 days
Secondary	1. The day of eventual tracheostomy 2. Organ Failure 3. The mortality at 28° day 4. Outcome at 6 months		1 year