Pulmonary Surgery and Protective Mechanical Ventilation (VPP)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Lung Neoplasms

Treatments: Procedure: mechanical ventilation; Other: tidal volume

Study type: Interventional

Funder types: Other

Identifiers

NCT00805077

P070119

Details and patient eligibility

About

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.

Full 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.

Enrollment: 347 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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347 participants in 2 patient groups

1

Experimental group

Description:

mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP

Treatment:

Procedure: mechanical ventilation

2

Other group

Description:

tidal volume of 10 ml/kg of ideal body weight without PEEP

Treatment:

Other: tidal volume