Pulmonary Surgery and Protective Mechanical Ventilation

NCT00805077 | Completed

• 1 other identifier: P070119
• Study Type: interventional
• Target: 347
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Major postoperative complications during the first 30 days after surgery

  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

  during the first 30 days after surgery

Study Arms (2)

1

EXPERIMENTAL

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

Procedure: mechanical ventilation

2

OTHER

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

Other: tidal volume

Interventions

mechanical ventilation PROCEDURE

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

1

tidal volume OTHER

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

2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary lung cancer.
• Elective Pneumonectomy or lobectomy or bilobectomy
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Departement d'Anesthesie Reanimation, Hopital Tenon

Paris, 75020, France

Location

Related Publications (1)

• 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.

  PMID: 29561278 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Postoperative Complications

Interventions

Respiration, Artificial; Tidal Volume

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy; Inspiratory Capacity; Vital Capacity; Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Emmanuel Marret, MD

  Hopital Tenon, Assistance Publique - Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: December 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: July 1, 2012
• Last Updated: July 29, 2013

Record last verified: 2013-07

Locations

FR (1)