The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)

Study Overview
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Brief Summary
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The study is intended to understand the benefit of Long Term Home care Therapy with nasal High flow in Bronchiectasis patients at home. Primary end point is to evaluate daily life compared to usual care and secondary is to evaluate the changes in lung function

Official Title
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The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care

Conditions
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Bronchiectasis Adult, Lung Infection, Quality of Life, Humidifier Lung, COPD Exacerbation, COPD Asthma

Intervention / Treatment
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* Device: High Flow Humidification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Bronchiectasis on HRCT Optimization of Therapy for at least 15 days before enrollment Autonomous patients with possibilities of practicing rehabilitations cycles Exclusion Criteria: OSAS (ODI>10/h) HOME NIV PH<7,35 - paO2< 60mmHg, paCo2> 55 mmHg Lung cancer Contraindication to high-flow nasal cannula (hfnc)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy with high flow humidification<br>The patients will be activated after enrollment with myAirvo2 device at home for 6 months before first observations | Device: High Flow Humidification<br>* myAirvo2 gives at home for long therapy treatment<br>|
| No Intervention: Therapy with usual care<br>The patients will be under usual care for observational | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvment Daily Life | measurement via questionary SGRQ | 1 year | 
| measurement of Sputum production | Microbiological Mesurement of sputum | 1 year | 
| measurement Exercise tolerance | measurement with 6 minutes walking test | 1 year | 
| Number of missed working or school day | Calculation of days of sick | 1 year | 
| time from first exacerbations | measurement of time dalay from last exacerbation | 1 year | 
| number of exacerbations including their durations and severity | counting form their clinic diary of number of exacerbation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Arterial Blood Glass | Arterial Blood Glass draw at time zero and time 1 | 1 year | 
| Unit of Nitric Oxide | Measurement with Nitric oxide device | 1 year | 
| Evaluation of Reactive C-Protein | comparation of blood draw | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiectasis, High Flow Therapy, Humidifcation, Lung Infection, Quality of life