Effect of Intrapulmonary Percussion Ventilation on Deposition of Inhaled Aerosols in Idiopathic Pulmonary Fibrosis

University Hospital, Tours9 enrolled

Overview

This protocol aims to evaluate the feasibility and benefit of Intrapulmonary Percussive Ventilation (IPV) to improve deposition of inhaled radiolabelled aerosols in fibrotic lung regions of patients with Idiopathic Pulmonary Fibrosis (IPF). Phase 1 of the protocol aims to identify the highest IPV pressure that is tolerated by individual patients. Secondary endpoints explore safety of IPV in IPF patients. Phase 2 of the protocol is a crossover randomized trial where patients will inhale 99mTc-labelled DiethyleneTriamine PentaAcetate (DTPA) aerosols with or without IPV. Aerosol deposition in HRCT-defined fibrotic regions of interest (ROI) is described by Single Photon Emission Computed Tomography (SPECT).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Intrapulmonary percussive ventilation is a non invasive ventilation technique where small boli or air are delivered, at adjustable frequency and pressure, to the upper airways though a mouthpiece. IPV is currently used in the clinic to aid with airway clearance in neuromuscular and airway diseases.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of IPF according to 2018 ATS/ERS/JRS/ALAT guidelines * Affiliation to health insurance * Signed informed consent Exclusion Criteria: * Other chronic lung disease * Airflow obstruction (FEV1/FVC\<0.7) * History of congestive heart failure * History of IPF exacerbation * History of lung cancer * Chronic cough precluding aerosol delivery and radioprotection * Claustrophobia * 24h/24 oxygen therapy * Any acute lung disease * Any potentially transmissible lung infection * Current or possible pregnancy and breastfeeding * Contra-indications to IPV : Emphysema, recent barotrauma, pneumothorax, pneumomediastinum * History of pneumothorax or pneumomediastinum * Patient unable to hold a mouthpiece tightly * Patient under legal protection (guardianship, curatorship) * Contraindication to the administration of Technescan DTPA

Outcomes

Primary Outcomes

Phase 1: Discomfort during IPV

IPV is delivered at increasing pressure (from 5 cm H2O to 40 cm H2O maximum pressure) and discomfort is assessed by a 5-level Likert scale ranging from "no discomfort" to "untolerable discomfort". IPV is stopped when discomfort is rated as "difficult to tolerate" whatever the pressure.

Time frame: immediately after IPV (visit V1)

Phase 2: Change between Control and IPV condition in amount of 99mTc-labelled DTPA aerosol deposited in fibrotic lung regions, reported to loaded dose

Following aerosol delivery, chest imaging is done with a SPECT device. SPECT images are fused to high resolution computed tomography (HRCT) images. Fibrotic lung regions regions of interest (ROI) are defined by analysis of HRCT images. SPECT signal in fibrotic ROI is reported to the radioactive dose that was loaded in the nebulizer Endpoint is radioactive signal in fibrotic ROI / loaded dose

Time frame: After delivery of radiolabelled aerosol under both Control and IPV condition (Visit 4/5) i.e. up to 1 month

Secondary Outcomes

Phase 1: Sensations associated with IPV in patients with IPF

5-levels Likert scales ranging from "not at all" to "Very much" are used to answer the following questions : "I have trouble breathing" "This thumps to much" "This is scary"

Time frame: immediately after IPV (Visit 1)

Phase 1: IPV-induced variations in dyspnea

Dyspnea-12 scale