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 statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Hospital, Grenoble

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 volunteers

Qualifiers

>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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • bronchoscope

    Procedure/Surgery

    procedure performed by bronchoscopy

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

1

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
2

ECOG-performance Status

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

Time frame
inclusion and Day 30
3

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

Time frame
During the 30 first days from intervention
4

hospitalization duration

Time frame
During the 30 first days from intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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