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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP |
|
| 2 | Other | tidal volume of 10 ml/kg of ideal body weight without PEEP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mechanical ventilation | Procedure | mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major postoperative complications during the first 30 days after surgery | the first 30 days after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Marret, MD | Hopital Tenon, Assistance Publique - Hopitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement d'Anesthesie Reanimation, Hopital Tenon | Paris | 75020 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29561278 | Derived | 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. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D013990 | Tidal Volume |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
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| tidal volume | Other | tidal volume of 10 ml/kg of ideal body weight without PEEP |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012138 |
| Respiratory Therapy |
| D007320 | Inspiratory Capacity |
| D014797 | Vital Capacity |
| D014109 | Total Lung Capacity |
| D008176 | Lung Volume Measurements |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |