We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Protective Versus Conventional Ventilation During Thoracic Surgery

This study is currently recruiting participants.
Verified January 2017 by Giorgio Della Rocca, Azienda Ospedaliera S. Maria della Misericordia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01504893
First Posted: January 6, 2012
Last Update Posted: January 31, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Giorgio Della Rocca, Azienda Ospedaliera S. Maria della Misericordia
  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: None (Open Label)
Primary Purpose: Prevention
Official Title: Multicenter Randomized Trial on Protective Ventilation Versus Conventional Ventilation During OLV in Patients Undergoing Thoracic Surgery

Resource links provided by NLM:


Further study details as provided by Giorgio Della Rocca, Azienda Ospedaliera S. Maria della Misericordia:

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


Secondary Outcome Measures:
  • 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 (%)


Estimated Enrollment: 2000
Study Start Date: September 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: August 2017 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Giorgio Della Rocca, MD, Prof +390432559501 giorgio.dellarocca@uniud.it
Contact: Nicola Langiano, MD +390432559506 niklang2001@yahoo.it

Locations
Italy
Department of Anesthesia and Intensive Care Unit Recruiting
Udine, Italy, 33100
Contact: Giorgio Della Rocca, MD, Prof    +390432559501    giorgio.dellarocca@uniud.it   
Contact: Nicola Langiano, MD    +390432559506    niklang2001@yahoo.it   
Principal Investigator: Giorgio Della Rocca, MD, Prof.         
Sub-Investigator: Nicola Langiano, MD         
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
  More Information

Publications:
Responsible Party: Giorgio Della Rocca, Professor, Azienda Ospedaliera S. Maria della Misericordia
ClinicalTrials.gov Identifier: NCT01504893     History of Changes
Other Study ID Numbers: protectiveOLV
First Submitted: December 30, 2011
First Posted: January 6, 2012
Last Update Posted: January 31, 2017
Last Verified: January 2017

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