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Clinical Trials/NCT00805077
NCT00805077
Completed
Not Applicable

Pulmonary Surgery and Protective Mechanical Ventilation

Assistance Publique - Hôpitaux de Paris1 site in 1 country347 target enrollmentDecember 2008
ConditionsLung Neoplasms

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Neoplasms
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
347
Locations
1
Primary Endpoint
Major postoperative complications during the first 30 days after surgery
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
July 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Major postoperative complications during the first 30 days after surgery

Time Frame: the first 30 days after surgery

Secondary Outcomes

  • 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)

Study Sites (1)

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