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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00538746

Enrollment

Unknown

Registered

2007-10-03

Start date

2005-02-28

Completion date

Unknown

Last updated

2007-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

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.

Interventions

DEVICEBIPAP

DEVICEPSV

DEVICEPSV + CPAP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
1. Days of intubation 2. Days of mechanical ventilation	28 days

Secondary

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

Countries

Italy

Contacts

Primary ContactPaolo Pelosi, Professor

ppelosi@hotmail.com0039-0332-278801

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026