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Evaluation of a Connected Parenteral Pump for Patients Treated by Home Parenteral Nutrition (HPN).

NCT04406766 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-01-09

No results posted yet for this study

Summary

Patients requiring long-term home parenteral nutrition (HPN) suffer from chronic intestinal insufficiency. The causes of this syndrome can be either anatomical (extensive resection of the small bowel) or functional (occlusion, pseudo-occlusion, malabsorption). Consequences mean that patients are unable to cover their oral energy and / or hydroelectrolytic needs.

As a result, these patients survive only through a nutritional support by the venous route (parenteral nutrition). However, this lifesaving therapy requires complex technological nutritional support issues at home, which will influence the personal life of the patients.

At home, HPN therapy is performed by nutrition pumps providing a constant flow and able to detect anomalies.

In this context, the development of connected systems that allow informations transmission could help patient's caregiving by the different persons involved in his follow-up (prescribing physicians, home support nurses, patients and relatives, manufacturers).

The main objective of this study is to evaluate the performance of an end-to-end data transmission chain which integrates a nutrition pump connected to a medical IoT module (developped by Maatel) able to send information to an applicative layer (software interface PatHView2, developped by Orange Labs) via different transmission modes : LoRaWAN (Long Range Wide-area network), BLE (Bluetooth Low Energy), GSM LTE-M (Global System for Mobile Communications, Long Term Evolution - Machine Type Communication).

Conditions

  • Parenteral Nutrition, Home

Interventions

DEVICE

Connected nutrition pump system

For the patient, it consists of the installation of the connected pump at his home for a duration of one month. Infusion data and events will be continuously collected and transmitted by the 4 different modes (LoRaAN, BLE , GSM and multimodality).Transmitted data won't be used to change the follow up of the patient. At the end of the month, patients will be solicited by an ergonomic engineer to complete a specific questionnaire in order to evaluate the future acceptability of the proposed solution.

Sponsors & Collaborators

  • Clinical Investigation Centre for Innovative Technology Network

    collaborator NETWORK

  • MAATEL

    collaborator UNKNOWN

  • Orange Labs

    collaborator UNKNOWN

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Eric Fontaine, MD · CHU Grenoble Alpes

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2021-07-16
Completion
2021-07-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04406766 on ClinicalTrials.gov