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

October 2, 2007 updated by: Università degli Studi dell'Insubria

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Varese, Italy, 21100
        • Recruiting
        • Ospedale di Circolo e Fondazione Macchi
        • Principal Investigator:
          • Paolo Pelosi, Professor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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
Experimental: 2
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
Experimental: 3
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1. Days of intubation 2. Days of mechanical ventilation
Time Frame: 28 days
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi dell'Insubria

Investigators

  • Principal Investigator: Paolo Pelosi, Professor, Universita' Degli Studi Dell'Insubria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Registration Dates

First Submitted

October 2, 2007

First Submitted That Met QC Criteria

October 2, 2007

First Posted (Estimate)

October 3, 2007

Study Record Updates

Last Update Posted (Estimate)

October 3, 2007

Last Update Submitted That Met QC Criteria

October 2, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1500 (CSL Behring)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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