About this trial
Bronchoscopic endoscopy has shown its effectiveness and reliability for the treatment (desobstruction or prothesis) of tumor-induced bronchial obstructions, particularly in the first few weeks. The presence of a lower airway prosthesis can lead to device obstruction requiring daily inhaled fluidification, bacterial colonization, migration of the prosthesis, or the appearance of obstructive or hemorrhagic granulomas.
The aim of this study is to evaluate the quality of life of patients after endobronchial treatment.
It is a prospective, descriptive, and multicentric (national) study. The main objective is to compare the total score on the Saint-George questionnaire at J7 of the interventional endoscopy compared to before the procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>18 years old
tumoral tracheobronchial obstruction and/or compression
proven solid cancer or suspicion
RR : ≥25/min
Disqualifiers
Minors
patients with neurological disabilities unable to understand and respond to the questionnaire
patients under guardianship or curatorship
Trial population
Inclusion Criteria: * \>18 years old * tumoral tracheobronchial obstruction and/or compression * proven solid cancer or suspicion * Acute respiratory distress (at least one of the 5): * RR : ≥25/min * Sign of respiratory struggle * Sign of respiratory failure * Oxygen therapy ≥5L/min * Ventilatory support (NIV, OHD or IT) : * Indication for therapeutic interventional endoscopy * No guardianship or curatorship * Non-hematological tumor Exclusion Criteria: * Minors * patients with neurological disabilities unable to understand and respond to the questionnaire * patients under guardianship or curatorship
Trial design
Cohort
Prospective
Treatments tested in this trial
bronchoscope
Procedure/Surgeryprocedure performed by bronchoscopy
Treatment groups
Trial outcomes
Primary outcomes
Saint George Score (quality of life)
Difference between Saint-George score at inclusion and Day 7. The scores for each dimension range from 0 to 100, with a score of 100 indicating excellent health.
Secondary outcomes
Saint-George and SF-12 (12-Item Short-Form Health Survey) score
Difference of these scores between inclusion and Day 30 The scores for each dimension of the Saint-George score range from 0 to 100, with a score of 100 indicating excellent health. The SF-12 score ranges from 1 to 60, with a score of 60 indicating very poor quality of life.
ECOG-performance Status
It ranges from 0 (fully active) to 5 (dead).
Duration of ventilatory support (mechanical ventilation, non-invasive ventilation, high-flow oxygen)
hospitalization duration
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: