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

Primary Purpose

Acute Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
BIPAP
PSV
PSV + CPAP
Sponsored by
Università degli Studi dell'Insubria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Ospedale di Circolo e Fondazione MacchiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

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%)

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.

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.

Outcomes

Primary Outcome Measures

1. Days of intubation 2. Days of mechanical ventilation

Secondary Outcome Measures

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

Full Information

First Posted
October 2, 2007
Last Updated
October 2, 2007
Sponsor
Università degli Studi dell'Insubria
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1. Study Identification

Unique Protocol Identification Number
NCT00538746
Brief Title
Effect of Increased Muscular Work During Different Weaning Strategies in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Università degli Studi dell'Insubria

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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%)
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Arm Title
3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BIPAP
Intervention Type
Device
Intervention Name(s)
PSV
Intervention Type
Device
Intervention Name(s)
PSV + CPAP
Primary Outcome Measure Information:
Title
1. Days of intubation 2. Days of mechanical ventilation
Time Frame
28 days
Secondary Outcome Measure Information:
Title
1. The day of eventual tracheostomy 2. Organ Failure 3. The mortality at 28° day 4. Outcome at 6 months
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Pelosi, Professor
Phone
0039-0332-278801
Email
ppelosi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Pelosi, Professor
Organizational Affiliation
Universita' degli Studi dell'Insubria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Pelosi, Professor
Phone
0039-0332-278801
Email
ppelosi@hotmail.com
First Name & Middle Initial & Last Name & Degree
Paolo Pelosi, Professor

12. IPD Sharing Statement

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

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