Protective Ventilation With Low Tidal Volume Versus an Ultraprotective Ventilatory Strategy for One-lung Ventilation in Patients Undergoing Thoracic Anesthesia. (U-PROVE)
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|ClinicalTrials.gov Identifier: NCT01504893|
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : March 27, 2018
The purpose of this study is to determine if a protective ventilatory strategy during one-lung ventilation (OLV) could reduce postoperative complications (PPCs) after thoracotomies or thoracoscopic pulmonary resection.
Primary endpoint: Evaluation of Acute Lung Injury (ALI) incidence
Secondary endpoint: postoperative outcome (hospital lenth of stay, morbidity, mortality and their correlation with preoperative comorbidity and surgery technique).
|Condition or disease||Intervention/treatment||Phase|
|Acute Lung Injury Acute Respiratory Distress Syndrome||Procedure: protective ventilation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Randomized Trial on Protective Ventilation Versus Conventional Ventilation During OLV in Patients Undergoing Thoracic Surgery|
|Actual Study Start Date :||September 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||September 2017|
Two-lung ventilation (TLV): tidal volume = 8 mL / kg, peak pressure streets ≤ 25 cm H2O, I: E = 1:2; after lung re-expansion to the closure of the chest will set a PEEP of 5 cmH2O
OLV (OLV): 4 mL / kg, peak airway pressure ≤ 35 cmH2O, respiratory rate <30, I:E = 1:2 / 1:3.
During OLV in case of desaturation (before increasing the FiO2) and / or within 1 hour you perform recruitment maneuvers followed by the setting of a PEEP of 5 cmH2O
Procedure: protective ventilation
Low tidal volume, PEEP and recruitment maneuver
No Intervention: conventional
Two-lung ventilation (TLV): tidal volume = 8 mL / kg, peak pressure ≤ 25 cmH2O airway; I: E = 1:2; after lung re-expansion to the closure of the chest will set a PEEP of 5 cmH2O
OLV (OLV): 8 mL / kg, peak airway pressure ≤ 35 cmH2O; I: E = 1:2.
- ALI [ Time Frame: hospital stay (aspected an average of 7 days) ]incidence of ALI (%)
- mortality [ Time Frame: 60 days ]To determine mortality (%)
- MORBIDITY [ Time Frame: hospital stay (7 days average aspected) ]To determine how many patients (%) would have any postoperative complications
- ICU admission [ Time Frame: hospital stay (7 days average aspected) ]To determine how many patients would require an ICU admission (%)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504893
|Department of Anesthesia and Intensive Care Unit|
|Udine, Italy, 33100|
|Principal Investigator:||Giorgio Della Rocca, MD, Prof||Azienda Ospedaliero-Universitaria S. Maria della Misericordia - Udine. Italy|