Concomitant Tracheostomy and Lung Resection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Concomitant Tracheostomy and Lung Resection in Patient With Low Postoperative Pulmonary Function

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: Tracheostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 79 years old preoperative diagnosis of suspected lung cancer patient considered operable according to the guidelines 30% < postoperative predicted FEV1 < 50% informed consent obtained by patient Exclusion Criteria: - age less than 18 and more than 79 pregnant woman preoperative tracheostomy postoperative vocal cord paralysis postoperative diaphragmatic paralysis (except for pneumonectomy) neuromuscular disorders previous pharyngeal or laryngeal surgery anatomical deformity of the neck making risky a tracheostomy consent refusal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Tracheostomy|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of mechanical ventilation days after operation until discharge |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 60 days mortality rate |  | 2 months | 
| ICU length of stay |  | 2 months | 
| hospital length of stay |  | 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 |  | 2 months | 
| cumulative incidence of postoperative cardiac complications defined as arrythmia needed treatment, cardiac failure needing inotrop drug, acute coronary stroke |  | 2 months | 
| laryngeal and tracheal complications |  | 2 months | 
| general complications |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracheostomy and thoracic surgery, postoperative complications, pulmonary surgical procedures, respiratory failure