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

N/ANot Yet RecruitingNCT07051161

University Hospital, Grenoble60 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Solid Cancer Bronchial Endoscopy Therapeutic Bronchofiberscopy

Interventions

bronchoscope

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

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.

Time frame: At inclusion, and 7 days after therapeutic bronchoscopy

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.

Time frame: at inclusion and Day 30

ECOG-performance Status

It ranges from 0 (fully active) to 5 (dead).

Time frame: inclusion and Day 30

Duration of ventilatory support (mechanical ventilation, non-invasive ventilation, high-flow oxygen)

Time frame: During the 30 first days from intervention

hospitalization duration

Time frame: During the 30 first days from intervention

anti-tumoral treatment

initiation or continuation of anti-tumour treatment (radiotherapy, chemotherapy, immunotherapy, targeted therapy)

Time frame: During the 30 first days from intervention

survival

Time frame: through study completion, an average of 1 year

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts