Effect of Increased Muscular Work During Different Weaning Strategies in Critically Ill Patients - Full Text View

Sponsored by:	Università degli Studi dell'Insubria
Information provided by:	Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:	NCT00538746

Purpose

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment

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
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538746

Contacts

Contact: Paolo Pelosi, Professor

0039-0332-278801

ppelosi@hotmail.com

Locations

Italy
Ospedale di Circolo e Fondazione Macchi	Recruiting
Varese, Italy, 21100
Contact: Paolo Pelosi, Professor 0039-0332-278801 ppelosi@hotmail.com
Principal Investigator: Paolo Pelosi, Professor

Sponsors and Collaborators

Università degli Studi dell'Insubria

Investigators

Principal Investigator:

Paolo Pelosi, Professor

Universita' degli Studi dell'Insubria

More Information

Study ID Numbers:	1500
Study First Received:	October 2, 2007
Last Updated:	October 2, 2007
ClinicalTrials.gov Identifier:	NCT00538746
Health Authority:	Italy: Ethics Committee

Study placed in the following topic categories:

Respiratory Insufficiency
Respiratory Tract Diseases
Critical Illness
Lung Diseases

Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome

ClinicalTrials.gov processed this record on January 16, 2009