Utility of a Weaning Protocol in ICU (WEAN)

ELENA PELI,MD

Status: Completed

Conditions: Weaning Failure

Treatments: Procedure: weaning protocol

Study type: Observational

Funder types: Other

Identifiers

NCT01877850

NPn1351

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

case

Description:

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

Treatment:

Procedure: weaning protocol

control

Description:

patients with any BWAP-M will be weaned by clinical judgment of physicians