Pulmonary Surgery and Protective Mechanical Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Lung Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

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

Group Type EXPERIMENTAL

mechanical ventilation

Intervention Type PROCEDURE

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

2

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

Group Type OTHER

tidal volume

Intervention Type OTHER

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

Interventions

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mechanical ventilation

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

Intervention Type PROCEDURE

tidal volume

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No