NCT01877850

Utility of a Weaning Protocol in ICU

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: ELENA PELI,MD · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Weaning Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-06-14
• Last updated: 2015-04-23

Locations

1 site across 1 country: Italy