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Pulmonary Surgery and Protective Mechanical Ventilation

18 Years
90 Years
Open (Enrolling)
Lung Neoplasms

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Trial Information

Pulmonary Surgery and Protective Mechanical Ventilation

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Major postoperative complications during the first 30 days after surgery

Outcome Time Frame:

the first 30 days after surgery

Safety Issue:


Principal Investigator

Emmanuel Marret, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hopital Tenon, Assistance Publique - Hopitaux de Paris


France: Direction Générale de la Santé

Study ID:




Start Date:

December 2008

Completion Date:

July 2012

Related Keywords:

  • Lung Neoplasms
  • interoperative care
  • Tidal volume
  • Postoperative complications
  • Pneumonectomy
  • Lobectomy
  • Mechanical ventilation
  • Neoplasms
  • Lung Neoplasms