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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01877850
Other study ID # NPn1351
Secondary ID
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


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
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