Clinical trial NCT00805077: Pulmonary Surgery and Protective Mechanical Ventilation
Official title: Pulmonary Surgery and Protective Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Keywords: interoperative care
Tidal volume
Postoperative complications
Pneumonectomy
Lobectomy
Mechanical ventilation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Major postoperative complications during the first 30 days after surgery
timeFrame: the first 30 days after surgery
Secondary outcomes:
measure: Minor postoperative complications during the first 30 days after surgery, length of stay in ICU and hospital, cancer recurrence, death
timeFrame: during the first 30 days after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement d'Anesthesie Reanimation, Hopital Tenon
Study officials:
affiliation: Hopital Tenon, Assistance Publique - Hopitaux de Paris
name: Emmanuel Marret, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marret E, Cinotti R, Berard L, Piriou V, Jobard J, Barrucand B, Radu D, Jaber S, Bonnet F; and the PPV study group. Protective ventilation during anaesthesia reduces major postoperative complications after lung cancer surgery: A double-blind randomised controlled trial. Eur J Anaesthesiol. 2018 Oct;35(10):727-735. doi: 10.1097/EJA.0000000000000804.