Concomitant Tracheostomy and Lung Resection

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: Tracheostomy

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU clermont-ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Marc Filaire, MD, University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (ANTICIPATED): June 1, 2010
• Study Completion (ANTICIPATED): June 1, 2010

Study Registration Dates

• First Submitted: January 5, 2010
• First Submitted That Met QC Criteria: January 20, 2010
• First Posted (ESTIMATE): January 21, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 19, 2011
• Last Update Submitted That Met QC Criteria: January 18, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: respiratory failure; postoperative complications; pulmonary surgical procedures; Tracheostomy and thoracic surgery
• Other Study ID Numbers: CHU-0064