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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)

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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

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).


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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

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.




Primary Outcome Measures :
  1. ALI [ Time Frame: hospital stay (aspected an average of 7 days) ]
    incidence of ALI (%)


Secondary Outcome Measures :
  1. mortality [ Time Frame: 60 days ]
    To determine mortality (%)

  2. MORBIDITY [ Time Frame: hospital stay (7 days average aspected) ]
    To determine how many patients (%) would have any postoperative complications

  3. ICU admission [ Time Frame: hospital stay (7 days average aspected) ]
    To determine how many patients would require an ICU admission (%)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Italy
Department of Anesthesia and Intensive Care Unit
Udine, Italy, 33100
Sponsors and Collaborators
Azienda Ospedaliera S. Maria della Misericordia
Investigators
Principal Investigator: Giorgio Della Rocca, MD, Prof Azienda Ospedaliero-Universitaria S. Maria della Misericordia - Udine. Italy

Publications:
Responsible Party: Giorgio Della Rocca, M.D., Azienda Ospedaliera S. Maria della Misericordia
ClinicalTrials.gov Identifier: NCT01504893     History of Changes
Other Study ID Numbers: protectiveOLV
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

Keywords provided by Giorgio Della Rocca, Azienda Ospedaliera S. Maria della Misericordia:
ventilation
PEEP
Acute Lung Injury
pneumonectomy
ARDS

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries