Concomitant Tracheostomy and Lung Resection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01053624
First received: January 5, 2010
Last updated: January 18, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Procedure: Tracheostomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Concomitant Tracheostomy and Lung Resection in Patient With Low Postoperative Pulmonary Function

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • number of mechanical ventilation days after operation until discharge [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 60 days mortality rate [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • ICU length of stay [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • hospital length of stay [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • cumulative incidence of postoperative cardiac complications defined as arrythmia needed treatment, cardiac failure needing inotrop drug, acute coronary stroke [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • laryngeal and tracheal complications [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • general complications [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: October 2001
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053624

Contacts
Contact: Patrick Lacarin 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick Lacarin    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Marc Filaire, MD University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01053624     History of Changes
Other Study ID Numbers: CHU-0064
Study First Received: January 5, 2010
Last Updated: January 18, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Tracheostomy and thoracic surgery
postoperative complications
pulmonary surgical procedures
respiratory failure

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 26, 2014