Effects of AD on VI in Patients With CF

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03655249
• Other study ID #: StLuc AD-VI
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 2021

Study information

• Verified date: November 2020
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: William Poncin, PT, PhD
• Phone: +3227642316
• Email: william.poncin[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Lung Clearance Index	LCI will be measured before, immediately after and 2h after the experimental or control conditions as well as before and after an hospitalization.	Up to 2 weeks
Secondary	Impedance variation	Impedance change in different lung zones	Up to 1 hour