Utility of a Weaning Protocol in ICU (WEAN)

Non Pharmacological Randomized Clinical Trial Designed to Evaluate the Difference of the Duration of Weaning Process From the Ventilator Between Protocol-driven Weaned Patients and Clinical-driven Weaned Patients.

The purpose of this study is to evaluate the difference of the duration of weaning process from the ventilator between protocol-driven weaned patients and clinical judgment driven weaned patients.

Study Overview

• Status: Completed
• Conditions: Weaning Failure
• Intervention / Treatment: Procedure: weaning protocol

Detailed Description

All patients with prolonged weaning and who required tracheostomy are enrolled in the study. These patients are randomized as "Case or Control" by a computer program.

Patients can start the weaning process when the acute phase of the respiratory failure has been resolved and pressure support ventilation was setted.

For all this patients are calculated modified-BWAP(BWAP-M) and TOBIN indexes. The "Case" patients started the weaning protocol process only if BWAP-M value is more than 15 or BWAP-M 10-15 with Tobin index < 100.

If not, the BWAP-M and Tobin will be calculated every day. The Control patients will start weaning by clinical judgement even if the BWAP-M value is less than 10.

For all patients are calculated: the duration of weaning process, the ICU length of stay and the duration of the mechanical ventilation.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy, 25128
    • Institute of Anesthesiology and Intensive Care of the University of Brescia, Spedali Civili, Italy,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

difficult to wean patients

Description

Inclusion Criteria:

1. all patients that are clinically identified as prolonged to wean (failed 3 spontaneous breathing trials or 7 days or more of mechanical ventilation after the initial unsuccessful trial) and tracheostomized in ICU
2. improvement or resolution of the underlying causes of acute respiratory failure ratio between pressure partial artery of oxygen and fraction inspired oxygen (PaO2/FiO2) >200 with fraction inspired oxygen (FiO2)< 0,45.
3. pressure supported ventilation at the time of enrollment.

Exclusion Criteria:

1. patients assessed as easy weaning and not tracheostomized;
2. patients already tracheostomized on admission to ICU.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
case; patients with BPAW-M more than 15 or between 10 and 15, but with Tobin <100 will be weaned with the weaning protocol by nurses	Procedure: weaning protocol; Reduction of pressure support ventilation (PSV) by 2cmH2O at a time to a maximum of 4cmH2O per day. When a patient was able to tolerate PSV less than 8 cmH2O for at least 120 minutes, the nurses started to reduce End Expiratory Positive Pressure (PEEP) by 2cmH2O at a time to a maximum of 4cmH2O per day. When a patient was able to tolerate PSV less than 8 cmH2O with PEEP less than 6 cmH2O, the nurses started SBT trial: Continuos Positive Pressure Airways of 6cmH2O for at least 120 minutes and following discontinuation from ventilator.
control; patients with any BWAP-M will be weaned by clinical judgment of physicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
duration of weaning	within the first 15 days (plus or minus 5 days) after start of weaning

Secondary Outcome Measures

Outcome Measure	Time Frame
duration of mechanical ventilation	within the first 12 days (plus or minus 10 days) after start of mechanical ventilation

Other Outcome Measures

Outcome Measure	Time Frame
ICU length of stay	within the first 26 days (plus or minus 22 days) after ICU recovery
success of weaning	spontaneous breathing for 48 hours

Collaborators and Investigators

• Sponsor: ELENA PELI,MD
• Investigators: Principal Investigator: Elena Peli

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: June 1, 2013
• First Submitted That Met QC Criteria: June 11, 2013
• First Posted (Estimate): June 14, 2013

Study Record Updates

• Last Update Posted (Estimate): April 23, 2015
• Last Update Submitted That Met QC Criteria: April 22, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: NPn1351