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Protective Ventilation With Low Tidal Volume Versus an Ultraprotective Ventilatory Strategy for One-lung Ventilation in Patients Undergoing Thoracic Anesthesia. (U-PROVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01504893
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Giorgio Della Rocca, Azienda Ospedaliera S. Maria della Misericordia

Tracking Information
First Submitted Date  ICMJE December 30, 2011
First Posted Date  ICMJE January 6, 2012
Last Update Posted Date March 27, 2018
Actual Study Start Date  ICMJE September 2013
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
ALI [ Time Frame: hospital stay (aspected an average of 7 days) ]
incidence of ALI (%)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
  • 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 (%)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protective Ventilation With Low Tidal Volume Versus an Ultraprotective Ventilatory Strategy for One-lung Ventilation in Patients Undergoing Thoracic Anesthesia.
Official Title  ICMJE Multicenter Randomized Trial on Protective Ventilation Versus Conventional Ventilation During OLV in Patients Undergoing Thoracic Surgery
Brief Summary

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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
Intervention  ICMJE Procedure: protective ventilation
Low tidal volume, PEEP and recruitment maneuver
Study Arms  ICMJE
  • Experimental: protective

    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

    Intervention: Procedure: protective ventilation
  • 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.

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2018)
1100
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2012)
2000
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients ≥ 18 years
  • ASA IV
  • Elective thoracotomies or thoracoscopic lung resection surgery (lobectomy, bilobectomy, pneumonectomy)

Exclusion Criteria:

  • Emergency surgery
  • Wedge resection or atypical resection
  • Non-resective lung surgery requiring OLV
  • Patients < 18 years
  • BMI < 20 and BMI > 29
  • Heart disease with ejection fraction <50% and/or severe valvulopathy
  • Pulmonary hypertension
  • Renal failure requiring dialytic treatment
  • Drug addiction
  • Mental retardation, depression and psychiatric disease
  • Motor or sensory deficit
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01504893
Other Study ID Numbers  ICMJE protectiveOLV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Giorgio Della Rocca, Azienda Ospedaliera S. Maria della Misericordia
Study Sponsor  ICMJE Azienda Ospedaliera S. Maria della Misericordia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Giorgio Della Rocca, MD, Prof Azienda Ospedaliero-Universitaria S. Maria della Misericordia - Udine. Italy
PRS Account Azienda Ospedaliera S. Maria della Misericordia
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP