Effects of AD on VI in Patients With CF

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)

Overall Status

Recruiting

CT.gov ID

NCT03655249

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will investigate the effects of a chest physiotherapy manual technique (autogenic drainage) on ventilation inhomogeneity in patients with cystic fibrosis. Lung clearance index (LCI) is the primary outcome

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Other: Autogenic drainage Drug: Aerosoltherapy	N/A

Detailed Description

This is a cross-over intervention assessing the effect of autogenic drainage on ventilation inhomogeneity in patients with cystic fibrosis.

Electrical impedance tomography and multiple breath nitrogen washout will be performed before, immediatly after and 2h post intervention. Each participant will receive either aerosoltherapy alone or in combination with chest physiotherapy on 2 consecutive days.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Participants receive one of two interventions during the first day, and receive the alternative intervention the following day. Interventions are : aerosoltherapy + autogenic drainage or aerosoltherapy aloneParticipants receive one of two interventions during the first day, and receive the alternative intervention the following day. Interventions are : aerosoltherapy + autogenic drainage or aerosoltherapy alone

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Autogenic Drainage on Ventilation Inhomogeneity in Patients With Cystic Fibrosis

Actual Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Asl + CPT Aerosotherapy + Autogenic drainage	Other: Autogenic drainage Autogenic drainage is an airway clearance technique that attempts to obtain the optimal airflow to evacuate the secretions. This technique uses modulation of inspiratory and expiratory airflow at different breathing level within the vital capacity. Drug: Aerosoltherapy Aerosolized drugs are individualized for each participants, in line with current standardized practice in our hospital. Those drugs will not be modified for the purpose of this study.
Active Comparator: Asl Aerosoltherapy alone	Drug: Aerosoltherapy Aerosolized drugs are individualized for each participants, in line with current standardized practice in our hospital. Those drugs will not be modified for the purpose of this study.

Arm

Intervention/Treatment

Experimental: Asl + CPT

Aerosotherapy + Autogenic drainage

Other: Autogenic drainage

Autogenic drainage is an airway clearance technique that attempts to obtain the optimal airflow to evacuate the secretions. This technique uses modulation of inspiratory and expiratory airflow at different breathing level within the vital capacity.

Drug: Aerosoltherapy

Aerosolized drugs are individualized for each participants, in line with current standardized practice in our hospital. Those drugs will not be modified for the purpose of this study.

Active Comparator: Asl

Aerosoltherapy alone

Drug: Aerosoltherapy

Aerosolized drugs are individualized for each participants, in line with current standardized practice in our hospital. Those drugs will not be modified for the purpose of this study.

Outcome Measures

Primary Outcome Measures

Change in Lung Clearance Index [Up to 2 weeks]
LCI will be measured before, immediately after and 2h after the experimental or control conditions as well as before and after an hospitalization.

Secondary Outcome Measures

Impedance variation [Up to 1 hour]
Impedance change in different lung zones

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Cystic fibrosis diagnosis
FEV1 > 40%
Able to sustain 30min of chest physiotherapy

Exclusion Criteria:

Presence of Burkoldheria cepacia or non tuberculous mycobacteria
Orthopedic, neuromuscular or cardiac disorder likely to impact respiratory system
Need for supplemental oxygen
Cardiac pacemaker or internal cardiac defibrillator