Utility of a Weaning Protocol in ICU

Weaning Failure Clinical Trial

— WEAN  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877850
• Other study ID #: NPn1351
• Status: Completed
• Phase: N/A
• First received: June 1, 2013
• Last updated: April 22, 2015
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: April 2015
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Weaning Failure

Intervention

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.

Locations

Country	Name	City	State
Italy	Institute of Anesthesiology and Intensive Care of the University of Brescia, Spedali Civili, Italy,	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
ELENA PELI,MD

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ICU length of stay		within the first 26 days (plus or minus 22 days) after ICU recovery	No
Other	success of weaning		spontaneous breathing for 48 hours	No
Primary	duration of weaning		within the first 15 days (plus or minus 5 days) after start of weaning	No
Secondary	duration of mechanical ventilation		within the first 12 days (plus or minus 10 days) after start of mechanical ventilation	No