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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
This protocol has been design 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
CHU Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGnumber of mechanical ventilation days after operation until discharge
Time frame: 2 months
60 days mortality rate
Time frame: 2 months
ICU length of stay
Time frame: 2 months
hospital length of stay
Time frame: 2 months
cumulative incidence of postoperative respiratory complications defined as pneumonia, re-ventilation, atelectasis needing fiberbronchoscopy, non cardiogenic pulmonary edema, air leakage >7 days, broncho-pleural fistula, pulmonary embolism, empyema
Time frame: 2 months
cumulative incidence of postoperative cardiac complications defined as arrythmia needed treatment, cardiac failure needing inotrop drug, acute coronary stroke
Time frame: 2 months
laryngeal and tracheal complications
Time frame: 2 months
general complications
Time frame: 2 months
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