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Pulmonary Surgery and Protective Mechanical Ventilation

Pulmonary Surgery and Protective Mechanical Ventilation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00805077
Acronym
VPP
Enrollment
347
Registered
2008-12-09
Start date
2008-12-31
Completion date
2012-07-31
Last updated
2013-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms

Keywords

interoperative care, Tidal volume, Postoperative complications, Pneumonectomy, Lobectomy, Mechanical ventilation

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.

Interventions

PROCEDUREmechanical ventilation

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

OTHERtidal volume

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Major postoperative complications during the first 30 days after surgerythe first 30 days after surgery

Secondary

MeasureTime frame
Minor postoperative complications during the first 30 days after surgery, length of stay in ICU and hospital, cancer recurrence, deathduring the first 30 days after surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026