Pulmonary Surgery and Protective Mechanical Ventilation

Lung Neoplasms Clinical Trial

— VPP  

Official title:

Pulmonary Surgery and Protective Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805077
• Other study ID #: P070119
• Status: Completed
• Phase: N/A
• First received: December 8, 2008
• Last updated: July 26, 2013
• Start date: December 2008
• Est. completion date: July 2012

Study information

• Verified date: July 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la SantéFrance: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: July 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
France	Departement d'Anesthesie Reanimation, Hopital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major postoperative complications during the first 30 days after surgery		the first 30 days after surgery	Yes
Secondary	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	Yes