Concomitant Tracheostomy and Lung Resection

University Hospital, Clermont-Ferrand

Status and phase: Unknown; Phase 3

Conditions: Lung Cancer

Treatments: Procedure: Tracheostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01053624

CHU-0064

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)