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

NCT03368365 | Unknown

• 3 other identifiers: 38RC16.1322016-A01060-5116-CHUG-17
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Monitoring; Home; Lung; Transplant; Hospitalization; Respiratory function at rest; Monitoring modem

Outcome Measures

Primary Outcomes (1)

• Analyze AMARS parameters to predict unplanned hospitalizations.

  Criterion including Sensitivity (Se), Specificity (Sp), Positive Predictive Value (VPP) and Negative Predictive Value (VPN) of AMARS parameters to predict unplanned hospitalization with measurement of the delay between changes in respiration at rest and unplanned hospitalization.

  12 months

Secondary Outcomes (3)

• Compare spirometry carried out at home and that performed in consultation / hospitalizations.

  12 months

• Determine the diagnostic specificities of the AMARS Analysis

  12 months

• Analyze the feasibility of pulmonary function monitoring at home by the Ventilotel (r) device in pulmonary transplant patients.

  12 months

Study Arms (1)

Ventilotel ®

OTHER

Using of the spirometer of Aqsitania company, Ventilotel ®.

Device: Ventilotel ®

Interventions

Ventilotel ® DEVICE

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

Ventilotel ®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having given informed consent in writing and affiliated to a social security scheme.

You may not qualify if:

• Home network coverage insufficient for data transmission.
• Proven psychiatric pathology.
• Cognitive problem significantly limiting the understanding of different instructions or evaluations.
• People referred to Articles L1121-5 to L1121-8 of the Code of Public Health.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Aqsitania SAS: collaborator
• AGIR à Dom: collaborator

Study Sites (2)

Grenoble University Hospital

La Tronche, Auvergne-Rhône-Alpes, 38700, France

RECRUITING

Lyon University Hospital

Lyon, Rhônes-Alpes, 69002, France

NOT YET RECRUITING

Study Officials

• Christophe Pison, Pr MD PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

• Jean-Christian Borel, PhD

  AGIR à Dom

  STUDY CHAIR

• José Labarère, Pr PhD

  Clinical Investigation Center - Technological Innovation (CIC-Innovation Technologique)

  STUDY CHAIR

Central Study Contacts

Aida Mandzo

CONTACT

+33 4 76 76 68 16; amandzo@chu-grenoble.com

Matthieu Lesgoirres

CONTACT

+33 6 62 34 79 98; m.lesgoirres@agiradom.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The occurrence of unplanned hospitalizations is independent of the spirometer used.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All transplanted subjects will be equiped with the Ventilotel (r) after their inclusion in the study.

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 11, 2017
• Study Start: February 7, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)