Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-02-23 @ 9:23 PM
Study NCT ID:
NCT01877850
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2013-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utility of a Weaning Protocol in ICU
Sponsor:
ELENA PELI,MD
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WEAN
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: