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Completed

NCT Number: NCT00805077

Pulmonary Surgery and Protective Mechanical Ventilation

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departement d'Anesthesie Reanimation, Hopital Tenon

Paris, 75020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mechanical ventilation

Procedure

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

Tidal volume

Other

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

Primary outcomes

  1. Major postoperative complications during the first 30 days after surgery

    Time frame: the first 30 days after surgery

Secondary outcomes

  1. Minor postoperative complications during the first 30 days after surgery, length of stay in ICU and hospital, cancer recurrence, death

    Time frame: during the first 30 days after surgery

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: VPP

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Dec 9, 2008
Registry last updated
Jul 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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