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Protective Versus Conventional Ventilation During Thoracic Surgery

This study is not yet open for participant recruitment.
Verified January 2012 by Azienda Ospedaliera S. Maria della Misericordia
Sponsor:
Information provided by (Responsible Party):
Giorgio Della Rocca, University of Udine
ClinicalTrials.gov Identifier:
NCT01504893
First received: December 30, 2011
Last updated: January 9, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of this study is to determine if a protective ventilatory strategy during one-lung ventilation (OLV) could reduce postoperative complications after thoracotomies or thoracoscopic pulmonary resection.

Primary endpoint: Evaluation of Acute Lung Injury (ALI) incidence

Secondary endpoint: postoperative outcome (hospital stay, morbidity, mortality and their correlation with preoperative comorbidity and surgery technique.


Condition Intervention
Acute Lung Injury
Acute Respiratory Distress Syndrome
 Procedure: protective ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Multicenter Randomized Trial on Protective Ventilation Versus Conventional Ventilation During OLV in Patients Undergoing Thoracic Surgery

Further study details as provided by Azienda Ospedaliera S. Maria della Misericordia:

Primary Outcome Measures:
  • ALI [ Time Frame: hospital stay (aspected an average of 7 days) ] [ Designated as safety issue: No ]
    incidence of ALI (%)


Secondary Outcome Measures:
  • mortality [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    To determine mortality (%)

  • MORBIDITY [ Time Frame: hospital stay (7 days average aspected) ] [ Designated as safety issue: No ]
    To determine how many patients (%) would have any postoperative complications

  • ICU admission [ Time Frame: hospital stay (7 days average aspected) ] [ Designated as safety issue: No ]
    To determine how many patients would require an ICU admission (%)


Estimated Enrollment: 2000
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504893

Contacts
Contact: Giorgio Della Rocca, Prof 00390432-559501 giorgio.dellarocca@uniud.it

Locations
Italy
Department of Anesthesia and Intensive Care Not yet recruiting
Udine, Italy, 33100
Contact: Giorgio Della Rocca, Prof     00390432-559501     giorgio.dellarocca@uniud.it    
Principal Investigator: Giorgio Della Rocca, Prof.            
Sponsors and Collaborators
Azienda Ospedaliera S. Maria della Misericordia
  More Information

Publications:

Responsible Party: Giorgio Della Rocca, Professor, University of Udine
ClinicalTrials.gov Identifier: NCT01504893     History of Changes
Other Study ID Numbers: protectiveOLV
Study First Received: December 30, 2011
Last Updated: January 9, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on May 19, 2013