Pulmonary Surgery and Protective Mechanical Ventilation (VPP)
Primary Purpose
Lung Neoplasms
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
mechanical ventilation
tidal volume
Sponsored by
About this trial
This is an interventional prevention trial for Lung Neoplasms focused on measuring interoperative care, Tidal volume, Postoperative complications, Pneumonectomy, Lobectomy, Mechanical ventilation
Eligibility Criteria
Inclusion Criteria:
- Primary lung cancer.
- Elective Pneumonectomy or lobectomy or bilobectomy
- Written informed consent
Exclusion Criteria:
- Patients undergoing surgical procedure other than pneumonectomy or lobectomy or bilobectomy
- Mesothelioma
- Liver cirrhosis
- Chronic renal failure
- Need for mechanical ventilation or non invasive ventilation (CPAP for obstructive sleep apnea syndrome for example) before surgery
- Emergency surgery
Sites / Locations
- Departement d'Anesthesie Reanimation, Hopital Tenon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
1
2
Arm Description
mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP
tidal volume of 10 ml/kg of ideal body weight without PEEP
Outcomes
Primary Outcome Measures
Major postoperative complications during the first 30 days after surgery
Secondary Outcome Measures
Minor postoperative complications during the first 30 days after surgery, length of stay in ICU and hospital, cancer recurrence, death
Full Information
NCT ID
NCT00805077
First Posted
December 8, 2008
Last Updated
July 26, 2013
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00805077
Brief Title
Pulmonary Surgery and Protective Mechanical Ventilation
Acronym
VPP
Official Title
Pulmonary Surgery and Protective Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to evaluate the efficacy and the safety of lung protective ventilation during anesthesia in patients undergoing pneumonectomy or lobectomy for lung cancer.
Detailed Description
Extended description of the protocol could be provided by the URC-EST, SAINT ANTOINE HOSPITAL, University of Paris-VI and by principal investigator.
Pneumonectomy or lobectomy is associated with a high risk for postoperative complication. The benefit of lung protective ventilation with low tidal volume has been demonstrated in patients with acute respiratory distress syndrome (ARDS) and acute lung injury (ALI). Recent clinical studies have suggested that mechanical ventilation with low tidal volume may also profit in others setting. Lung protective ventilation during anaesthesia has been found to limit the inflammatory response in the lung and to decrease postoperative systemic inflammatory response. However, others trials did not found benefit of protective ventilation strategy during anaesthesia.
This study will be a randomized, controlled, doubled blind trial comparing two management ventilator strategies during anaesthesia for thoracotomy. Only patients undergoing pneumonectomy or lobectomy for lung primitive cancer will be included in this trial. During anesthesia, one group will receive mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP and the other will receive tidal volume of 10 ml/kg of ideal body weight without PEEP. After surgery, data concerning oxygen delivery, blood analysis, complications, cancer recurrence and death will be collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
Keywords
interoperative care, Tidal volume, Postoperative complications, Pneumonectomy, Lobectomy, Mechanical ventilation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
347 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP
Arm Title
2
Arm Type
Other
Arm Description
tidal volume of 10 ml/kg of ideal body weight without PEEP
Intervention Type
Procedure
Intervention Name(s)
mechanical ventilation
Intervention Description
mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP
Intervention Type
Other
Intervention Name(s)
tidal volume
Intervention Description
tidal volume of 10 ml/kg of ideal body weight without PEEP
Primary Outcome Measure Information:
Title
Major postoperative complications during the first 30 days after surgery
Time Frame
the first 30 days after surgery
Secondary Outcome Measure Information:
Title
Minor postoperative complications during the first 30 days after surgery, length of stay in ICU and hospital, cancer recurrence, death
Time Frame
during the first 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary lung cancer.
Elective Pneumonectomy or lobectomy or bilobectomy
Written informed consent
Exclusion Criteria:
Patients undergoing surgical procedure other than pneumonectomy or lobectomy or bilobectomy
Mesothelioma
Liver cirrhosis
Chronic renal failure
Need for mechanical ventilation or non invasive ventilation (CPAP for obstructive sleep apnea syndrome for example) before surgery
Emergency surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Marret, MD
Organizational Affiliation
Hopital Tenon, Assistance Publique - Hopitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement d'Anesthesie Reanimation, Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
29561278
Citation
Marret E, Cinotti R, Berard L, Piriou V, Jobard J, Barrucand B, Radu D, Jaber S, Bonnet F; and the PPV study group. Protective ventilation during anaesthesia reduces major postoperative complications after lung cancer surgery: A double-blind randomised controlled trial. Eur J Anaesthesiol. 2018 Oct;35(10):727-735. doi: 10.1097/EJA.0000000000000804.
Results Reference
derived
Learn more about this trial
Pulmonary Surgery and Protective Mechanical Ventilation
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