Validation of the Respiratory Function of Pulmonary Transplants to Anticipate Unplanned Hospitalizations

Summary

Acute cellular and/or humoral rejection and early graft infections after pulmonary transplant (\<2.5 years) are common and can lead to chronic dysfunction of the transplanted organ or Chronic Lung Allograft Dysfunction, CLAD. These complications increase the number of unplanned and life-threatening hospitalizations. Regular multi-weekly monitoring of respiratory function is necessary to detect these complications early and to make their management more effective and less costly. Monitoring by micro spirometers with forced expirations at home proved difficult to perform (patient and effort dependent), often poorly coordinated (transmission of data to practitioners) and not sensitive in the prediction of post-transplant complications. Aqsitania has developed an innovative analysis of resting respiratory signals. This innovative analysis is called "Anharmonic Morphological Analysis of Respiratory Signals (AMARS)". This automated analysis is based on a measurement of the respiration collected by a spirometry device communicating and allowing a remote home monitoring (Ventilotel®). We hypothesize that this Anharmonic Morphological Analysis of Respiratory Signals at rest could predict unplanned hospitalizations and allow for more reliable monitoring of pulmonary transplant patients. Inclusion visit: Explanation of the study and collection of consent, measurement of resting breath and explanation on the mode of use of the measuring device at home, clinical examination, respiratory functional exploration. Follow-up at home for 12 months with a resting breath measurement for 2 to 3 min, in the morning on waking and in the evening before bed, 2 days / week with automatic sending of data on the Aqsitania server. The first month, a visit at home can be made if the subject feels the need. At each measurement, Aqsitania transmits the data in the e-CRF, a report that gives the anonymised values of the markers and the current personal respiratory profile. In order to avoid "motivational" bias, patients will have instructions to use the device but no "coaching" call will be made during the study. Patients will have their monthly or quarterly follow-up visits, including clinical examination, respiratory functional exploration and an analysis of adverse events. No additional search-specific visits will be carried out.

Conditions

• Lung Transplant; Complications

Interventions

DEVICE

Ventilotel ®

Using of the spirometer of Aqsitania company, Ventilotel ®, to analyse the respiratory function at rest and to predict unplanned hospitalizations.

Sponsors & Collaborators

• Aqsitania SAS

  collaborator UNKNOWN

• AGIR à Dom

  collaborator OTHER

• University Hospital, Grenoble

  lead OTHER

Principal Investigators

• Christophe Pison, Pr MD PhD · University Hospital, Grenoble

• Jean-Christian Borel, PhD · AGIR à Dom

• José Labarère, Pr PhD · Clinical Investigation Center - Technological Innovation (CIC-Innovation Technologique)

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-07

Primary Completion

2019-03-31

Completion

2019-03-31

Countries

• France

Study Locations