Concomitant Tracheostomy and Lung Resection

Phase 3

• Conditions: Lung Cancer

• Registration Number: NCT01053624
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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

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 Timeline

• Study Start: 2001-10
• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-18
• Last Update Posted: 2011-01-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
number of mechanical ventilation days after operation until discharge	2 months

Secondary Outcome Measures

Name	Time	Method
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
general complications	2 months
laryngeal and tracheal complications	2 months

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France