Concomitant Tracheostomy and Lung Resection

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01053624
• Other study ID #: CHU-0064
• Status: Recruiting
• Phase: Phase 3
• First received: January 5, 2010
• Last updated: January 18, 2011
• Start date: October 2001
• Est. completion date: June 2010

Study information

• Verified date: January 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick Lacarin
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of mechanical ventilation days after operation until discharge		2 months	Yes
Secondary	60 days mortality rate		2 months	Yes
Secondary	ICU length of stay		2 months	Yes
Secondary	hospital length of stay		2 months	Yes
Secondary	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	Yes
Secondary	cumulative incidence of postoperative cardiac complications defined as arrythmia needed treatment, cardiac failure needing inotrop drug, acute coronary stroke		2 months	Yes
Secondary	laryngeal and tracheal complications		2 months	Yes
Secondary	general complications		2 months	Yes