Pulmonary Surgery and Protective Mechanical Ventilation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pulmonary Surgery and Protective Mechanical Ventilation

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Procedure: mechanical ventilation
* Other: tidal volume


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP | Procedure: mechanical ventilation<br>* mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP<br>|
| Other: 2<br>tidal volume of 10 ml/kg of ideal body weight without PEEP | Other: tidal volume<br>* tidal volume of 10 ml/kg of ideal body weight without PEEP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major postoperative complications during the first 30 days after surgery |  | the first 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor postoperative complications during the first 30 days after surgery, length of stay in ICU and hospital, cancer recurrence, death |  | during the first 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interoperative care, Tidal volume, Postoperative complications, Pneumonectomy, Lobectomy, Mechanical ventilation