Pulmonary Surgery and Protective Mechanical Ventilation (VPP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00805077
First received: December 8, 2008
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Lung Neoplasms
Procedure: mechanical ventilation
Other: tidal volume

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Pulmonary Surgery and Protective Mechanical Ventilation

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Major postoperative complications during the first 30 days after surgery [ Time Frame: the first 30 days after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 347
Study Start Date: December 2008
Study Completion Date: July 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP
Procedure: mechanical ventilation
mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP
Other Name: mechanical ventilation
2
tidal volume of 10 ml/kg of ideal body weight without PEEP
Other: tidal volume
tidal volume of 10 ml/kg of ideal body weight without PEEP
Other Name: tidal volume

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805077

Locations
France
Departement d'Anesthesie Reanimation, Hopital Tenon
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Emmanuel Marret, MD Hopital Tenon, Assistance Publique - Hopitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00805077     History of Changes
Other Study ID Numbers: P070119
Study First Received: December 8, 2008
Last Updated: July 26, 2013
Health Authority: France: Direction Générale de la Santé
France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
interoperative care
Tidal volume
Postoperative complications
Pneumonectomy
Lobectomy
Mechanical ventilation

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014