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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prototype software | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric NOLL, MD | Hôpitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Strasbourg | Strasbourg | 67000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38609723 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prototype Software | All study participants received the same intervention, i.e. use of our novel CDSS device, in this single-arm study. Before the intervention they received education from study personnel about the purpose and the use of the experimental device. After the surgical procedure, patients were given the experimental device on postoperative days 1 and 2 from 9 am to 5 pm. They were also given another educational session about the use of the device. The device was configured each day by study personnel before being handed to the patient. The configuration included medical prescriptions related to pain, PONV and constipation. The patients were instructed to press the room call button each time they experienced significant symptoms of pain, PONV or constipation to request help from the hospital team providing their routine care. In the educational session, they were instructed to activate the experimental device and go through the questions displayed, after they pressed the room call button. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
7 patients did not activate the device or activated unintentionally
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| ID | Title | Description |
|---|---|---|
| BG000 | Prototype Software | All study participants received the same intervention, i.e. use of our novel CDSS device, in this single-arm study. Before the intervention they received education from study personnel about the purpose and the use of the experimental device. After the surgical procedure, patients were given the experimental device on postoperative days 1 and 2 from 9 am to 5 pm. They were also given another educational session about the use of the device. The device was configured each day by study personnel before being handed to the patient. The configuration included medical prescriptions related to pain, PONV and constipation. The patients were instructed to press the room call button each time they experienced significant symptoms of pain, PONV or constipation to request help from the hospital team providing their routine care. In the educational session, they were instructed to activate the experimental device and go through the questions displayed, after they pressed the room call button. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The patient may find themselves in several situations where they need advice. | Posted | Count of Units | recommendation pairs (Number of matches) | Day 2 post operative | recommendation pairs (Number of matches) | recommendation pairs (Number of matches) |
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prototype Software | All study participants received the same intervention, i.e. use of our novel CDSS device, in this single-arm study. Before the intervention they received education from study personnel about the purpose and the use of the experimental device. After the surgical procedure, patients were given the experimental device on postoperative days 1 and 2 from 9 am to 5 pm. They were also given another educational session about the use of the device. The device was configured each day by study personnel before being handed to the patient. The configuration included medical prescriptions related to pain, PONV and constipation. The patients were instructed to press the room call button each time they experienced significant symptoms of pain, PONV or constipation to request help from the hospital team providing their routine care. In the educational session, they were instructed to activate the experimental device and go through the questions displayed, after they pressed the room call button. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Noll | Hôpitaux Universitaires de Strasbourg (HUS)/ Strasbourg University Hospital | 03 88 12 70 76 | eric.noll@chru-strasbourg.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2023 | Apr 10, 2026 | Prot_SAP_000.pdf |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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