Utility of a Weaning Protocol in ICU

Completed

• Conditions: Weaning Failure
• Interventions: Procedure: weaning protocol

• Registration Number: NCT01877850
• Lead Sponsor: ELENA PELI,MD

Brief 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.

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 Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-01
• Study First Submitted QC: 2013-06-11
• Study First Posted: 2013-06-14
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-22
• Last Update Posted: 2015-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
case	weaning protocol	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

Primary Outcome Measures

Name	Time	Method
duration of weaning	within the first 15 days (plus or minus 5 days) after start of weaning

Secondary Outcome Measures

Name	Time	Method
duration of mechanical ventilation	within the first 12 days (plus or minus 10 days) after start of mechanical ventilation

Trial Locations

Locations (1)

Institute of Anesthesiology and Intensive Care of the University of Brescia, Spedali Civili, Italy,; 🇮🇹 Brescia, Italy