Impact of Interventional Endoscopy on Quality of Life in Patients With Acute Respiratory Distress Due to Tumor Compression or Obstruction of the Lower Respiratory Tract
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Primary Endpoint
- Saint George Score (quality of life)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •patients with neurological disabilities unable to understand and respond to the questionnaire
- •patients under guardianship or curatorship
Outcomes
Primary Outcomes
Saint George Score (quality of life)
Time Frame: At inclusion, and 7 days after therapeutic bronchoscopy
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
- anti-tumoral treatment(During the 30 first days from intervention)
- survival(through study completion, an average of 1 year)
- ECOG-performance Status(inclusion and Day 30)
- Duration of ventilatory support (mechanical ventilation, non-invasive ventilation, high-flow oxygen)(During the 30 first days from intervention)
- Saint-George and SF-12 (12-Item Short-Form Health Survey) score(at inclusion and Day 30)
- hospitalization duration(During the 30 first days from intervention)