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


Phase 3
18 Years
79 Years
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

number of mechanical ventilation days after operation until discharge

Outcome Time Frame:

2 months

Safety Issue:

Yes

Principal Investigator

Marc Filaire, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Clermont-Ferrand

Authority:

France: Ministry of Health

Study ID:

CHU-0064

NCT ID:

NCT01053624

Start Date:

October 2001

Completion Date:

June 2010

Related Keywords:

  • Lung Cancer
  • Tracheostomy and thoracic surgery
  • postoperative complications
  • pulmonary surgical procedures
  • respiratory failure
  • Lung Neoplasms

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