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

NCT04406766 | Terminated

• 1 other identifier: 38RC19.343
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Connected feeding pump; Reduction of costs due to late management of complications; Patients quality of life improvement; Clinical management of patients' pathology improvement

Outcome Measures

Primary Outcomes (1)

• Ratio of all data and anomaly events correctly transmitted from the connected infusion pump to the software interface.

  Evaluate the ratio of data (volume administered with the perfusion cycles over 24 hours; duration, velocity rate and mode of the perfusions) and events (occlusion of the venous route and presence of bubble in the infusion line) correctly transmitted in different transmission modalities (LoRaWan, BLE+GSM, GSM LTE-M, multimodality) from the connected infusion pump to the software interface.

  1 month

Secondary Outcomes (6)

• Volume of all data and anomaly events correctly transmitted from the nutrition pump to the software interface, compared to the volume of data to be transmitted.

  1 month

• Type and variable (value / field / date / time) for data and events from extracted files : - from the pump before the IoT module; - from the software interface.

  1 month

• Frequency and typology of problems encountered.

  1 month

• - Quantitative evaluation: number of cases in which the physician would have changed the patient follow-up over the entire study ; - Qualitative evaluation: nature of the follow-up change (no change, delayed change, immediate change).

  1 month

• Analysis of the efficacy, the efficiency, the difficulties and usage errors of the software interface by the medical team according to specific scenarios tests performed with an ergonomist (with voice and screen recording).

  1 month

Study Arms (1)

Connected nutrition pump system

EXPERIMENTAL

Device: Connected nutrition pump system

Interventions

Connected nutrition pump system DEVICE

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.

Connected nutrition pump system

Eligibility Criteria

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

You may qualify if:

• Age \< 18 years
• Patient receiving a home parenteral nutrition (HPN) and followed by the Artificial Nutrition Service of the CHUGA
• Patient carrying out all his infusions at home during the month of use of the connected pump (constraint due to the LoRaWAn transmission mode)
• Patient affiliated to the French social security system or an equivalent system
• Patient who has signed consent form

You may not qualify if:

• Presenting any other pathology or treatment that the physician may deem incompatible with this study
• Protected persons (patient concerned by articles L1121-5, L1121-6, L1121-8 of the French public health code)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Clinical Investigation Centre for Innovative Technology Network: collaborator
• MAATEL: collaborator
• Orange Labs: collaborator

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38000, France

Location

Related Publications (2)

• Pironi L, Miglioli M, Ruggeri E, Longo N, Suriani U, Maselli S, Gnudi S, Barbara L. Home parenteral nutrition for the management of chronic intestinal failure: a 34 patient-year experience. Ital J Gastroenterol. 1993 Oct;25(8):411-8.

  PMID: 8286774 BACKGROUND

• Detsky AS, McLaughlin JR, Abrams HB, L'Abbe KA, Whitwell J, Bombardier C, Jeejeebhoy KN. Quality of life of patients on long-term total parenteral nutrition at home. J Gen Intern Med. 1986 Jan-Feb;1(1):26-33. doi: 10.1007/BF02596321.

  PMID: 3095514 BACKGROUND

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Fontaine, MD

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 28, 2020
• Study Start: September 28, 2020
• Primary Completion: July 16, 2021
• Study Completion: July 16, 2021
• Last Updated: January 9, 2023

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)