Institute of Anesthesiology and Intensive Care of the University of Brescia, Spedali Civili, Italy,
Brescia, 25128, Italy
NCT Number: NCT01877850
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.
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Observational
Brescia, 25128, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: within the first 15 days (plus or minus 5 days) after start of weaning
Time frame: within the first 12 days (plus or minus 10 days) after start of mechanical ventilation
Time frame: within the first 26 days (plus or minus 22 days) after ICU recovery
Time frame: spontaneous breathing for 48 hours
ELENA PELI,MD
Other
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.
Acronym: WEAN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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