Validation of the Rest Respiratory Function Monitoring of Pulmonary Transplants at Home to Anticipate Unplanned Hospitalizations

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 respiratory signals at rest. 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.

Individual benefit (s): From an individual point of view, this is a descriptive study with no direct benefit expected for the patients participating in the research. Nevertheless, if the hypothesis is confirmed, the benefits for the transplant patients will be considerable because a prediction of the occurrence of post-transplant complications at a much earlier stage, probably infra-clinical, would allow a more efficient management thus a better prognosis for these patients grafted. This is added the advantage of the telecommunication system which will allow a reliable and automated transmission of the parameters evaluated at home, which can improve the coordination of the care and the reactivation of the caregivers. Lastly, it is possible to emphasize the medical and psychological safety of the patient by the use of this device, which is an important element for this type of risky situation.

Collective Benefit (s): Provided that subsequent randomized studies confirm this, it is likely that monitoring of respiratory function by this innovative connected device will significantly reduce the morbidity and mortality of post-transplant follow-up. Collective benefits are also economic. Significant savings in the use of care and hospitalizations avoided or reduced in anticipation of the risk of serious complications following pulmonary transplantation can be expected from this new mode of surveillance. The challenge would be to significantly increase the cost effectiveness of this costly therapeutic in 2015 to eventually have a QALY <100 000 €.

Expected benefits: If the analysis of respiration at home allows prediction of complications after a pulmonary transplant, it will then be necessary to demonstrate that an early management strategy, probably subclinical and based on this analysis, Avoid post-transplant complications, reduce morbidity and mortality and care for pulmonary transplant patients. The results for this research are therefore considerable.

Medical device used in research: