Clinical trial NCT01053624: Concomitant Tracheostomy and Lung Resection
Official title: Concomitant Tracheostomy and Lung Resection in Patient With Low Postoperative Pulmonary Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lung Cancer
Keywords: Tracheostomy and thoracic surgery
postoperative complications
pulmonary surgical procedures
respiratory failure
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2010-01-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of mechanical ventilation days after operation until discharge
timeFrame: 2 months
Secondary outcomes:
measure: 60 days mortality rate
timeFrame: 2 months
measure: ICU length of stay
timeFrame: 2 months
measure: hospital length of stay
timeFrame: 2 months
measure: 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
timeFrame: 2 months
measure: cumulative incidence of postoperative cardiac complications defined as arrythmia needed treatment, cardiac failure needing inotrop drug, acute coronary stroke
timeFrame: 2 months
measure: laryngeal and tracheal complications
timeFrame: 2 months
measure: general complications
timeFrame: 2 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Marc Filaire, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Filaire M, Tardy MM, Richard R, Naamee A, Chadeyras JB, Da Costa V, Bailly P, Eisenmann N, Pereira B, Merle P, Galvaing G. Prophylactic tracheotomy and lung cancer resection in patient with low predictive pulmonary function: a randomized clinical trials. Chin Clin Oncol. 2015 Dec;4(4):40. doi: 10.3978/j.issn.2304-3865.2015.11.05.