Study of a Prototype Software to Help Surgical Patients Manage Their Pain Medication

NCT05707247 | Completed Results

• 1 other identifier: 8706
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The experimental medical device is a prototype software. The device comes in the form of a smartphone with a touch interface. The smartphone used to support the software is a commercial smartphone marked CE. The study aims at assessing the feasibility of the use of this expert, patient- decision support systems. The study hypothesis is that the clinical use of the experimental device is feasible.

Conditions

Post-operative Situation

Keywords

prototype software; patient interface; experimental medical device

Outcome Measures

Primary Outcomes (1)

• Rate of Agreement Between the Recommendations of the INSAMED Computer Tool and the Recommendations Made by a Healthcare Professional From the Research Team Based on the Best Practice Algorithm.

  Recommendation pairs were analyzed in this Outcome Measure for the number of recommendation pairs that matched recommendations between the INSAMED Computer Tool and the Healthcare Professional, The recommendations of the INSAMED computer tool will be collected by extracting the history from the digital interface (commercial smartphone) hosting the expert system. The recommendations established by a caregiver from the research team based on a best practice algorithm will be determined: After receiving the device activation message, a caregiver (registered nurse) from the research team will establish a recommendation based on the medical algorithm for treating the symptom, medical prescriptions and the patient's interview without consulting INSAMED. The response provided by the nurse in charge of the patient is not used as the gold standard because, in practice, the responses provided may differ from the medical ideal (e.g. unavailability of staff or non-compliance with the care plan).

  Day 2 post operative

Study Arms (1)

prototype software

EXPERIMENTAL

Device: software

Interventions

software DEVICE

The experimental medical device is a prototype software. It is a patient interface. The device comes in the form of a smartphone with a touch screen

prototype software

Eligibility Criteria

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

You may qualify if:

• Male or Female 18 years or older (no upper age limit)
• Operated within a surgical department of of the Hautepierre University Hospitals of Strasbourg
• Patient understanding and reading French
• Subject neurosensorially able of interacting with a tactile electronical interface
• Subject able to understand research objectives, risks and provide dated and signed informed consent
• Subject covered by a health insurance scheme

You may not qualify if:

• Patient with neuropsychiatric or sensory disorders that may interfere with their use of the visual interface
• Unable to provide informed information (subject in emergency, difficulty understanding the subject, etc.)
• Pregnant or lactating woman (on declaration)
• Patient under safeguard of justice, under guardianship, under curatorship

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

Related Publications (1)

• Noll E, Noll-Burgin M, Bonnomet F, Reiter-Schatz A, Gourieux B, Bennett-Guerrero E, Goetsch T, Meyer N, Pottecher J. Knowledge-based, computerized, patient clinical decision support system for perioperative pain, nausea and constipation management: a clinical feasibility study. J Clin Monit Comput. 2024 Aug;38(4):907-913. doi: 10.1007/s10877-024-01148-z. Epub 2024 Apr 12.

  PMID: 38609723 RESULT

Limitations and Caveats

Perioperative care is characterized by the introduction of multiple symptom-specific treatments for pain, PONV and constipation in a period of patients' physical and psychological vulnerability \[6, 20, 21\]. These symptomspecific treatments are multimodal and frequently include systemic and "on-demand", pharmacological and nonpharmacological therapies \[6, 21\]. Moreover, some of these symptom-specific therapies may simultaneously ease some symptoms and trigger clinical adverse events.

Results Point of Contact

• Title: Eric Noll
• Organization: Hôpitaux Universitaires de Strasbourg (HUS)/ Strasbourg University Hospital

eric.noll@chru-strasbourg.fr

03 88 12 70 76

Study Officials

• Eric NOLL, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: January 12, 2023
• First Posted: January 31, 2023
• Study Start: February 13, 2023
• Primary Completion: June 28, 2023
• Study Completion: July 4, 2023
• Last Updated: April 14, 2026
• Results First Posted: April 14, 2026

Record last verified: 2026-03

Locations

FR (1)