Pulmonary Surgery and Protective Mechanical Ventilation

Not Applicable

Completed

• Conditions: Lung Neoplasms
• Interventions: Procedure: mechanical ventilation; Other: tidal volume

• Registration Number: NCT00805077
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-09
• Primary Completion: 2011-11
• Study Completion: 2012-07
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-26
• Last Update Posted: 2013-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

Inclusion Criteria

• Primary lung cancer.
• Elective Pneumonectomy or lobectomy or bilobectomy
• Written informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	mechanical ventilation	mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP
2	tidal volume	tidal volume of 10 ml/kg of ideal body weight without PEEP

Primary Outcome Measures

Name	Time	Method
Major postoperative complications during the first 30 days after surgery	the first 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Departement d'Anesthesie Reanimation, Hopital Tenon; 🇫🇷 Paris, France