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Concomitant Tracheostomy and Lung Resection

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ClinicalTrials.gov Identifier: NCT01053624
Recruitment Status : Unknown
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : January 21, 2010
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: Tracheostomy Phase 3

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Concomitant Tracheostomy and Lung Resection in Patient With Low Postoperative Pulmonary Function
Study Start Date : October 2001
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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


Primary Outcome Measures :
  1. number of mechanical ventilation days after operation until discharge [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. 60 days mortality rate [ Time Frame: 2 months ]
  2. ICU length of stay [ Time Frame: 2 months ]
  3. hospital length of stay [ Time Frame: 2 months ]
  4. 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 ]
  5. cumulative incidence of postoperative cardiac complications defined as arrythmia needed treatment, cardiac failure needing inotrop drug, acute coronary stroke [ Time Frame: 2 months ]
  6. laryngeal and tracheal complications [ Time Frame: 2 months ]
  7. general complications [ Time Frame: 2 months ]


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01053624     History of Changes
Other Study ID Numbers: CHU-0064
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: January 2011

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