Lung Cancer Clinical Trial
Official title:
Concomitant Tracheostomy and Lung Resection in Patient With Low Postoperative Pulmonary Function
This protocol has been designed to determine if tracheostomy performed immediately after lung operation (i.e. concomitant tracheotomy) could improve the postoperative outcome of high risk patients. We hypothesized that concomitant tracheotomy could reduce the length of mechanical ventilation and the number of respiratory complications.
Background: Respiratory failure after lung resection is a major complication. Several
studies suggest that low predictive postoperative pulmonary function is a predictive factor
of mechanical ventilation (MV). In critically ill patients requiring MV, early tracheostomy
may shorten the duration of MV and length of stay in intensive care.
Study objective: To determine whether concomitant tracheostomy (CT) would decrease the
length of MV and improves outcome in patient with predictive postoperative forced expiratory
volume in 1 second (FEV1ppo) < 50%. We call CT a tracheostomy performed immediately after
the lung resection under the same general anesthesia.
Method: An open monocentric randomized controlled trial has been design. Inclusion and
exclusion criteria are mentioned below. FEV1ppo will be calculated by the mean of the
scintigraphic method for pneumonectomy and by the mean of the number of resected segments
for lobectomy and segmentectomy. Randomization will be made the day before the operation.
The procedure will be an open surgical tracheostomy. A daily data base will be completed
from randomization until discharge. The primary and secondary criteria are mentioned below.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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