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The purpose of this study is to investigate the feasibility of using the Swiftsure Complete Care System (CCS) device as an adjunct to standard oral care procedures among intubated adult patients undergoing mechanical ventilation in the intensive care unit (ICU).
This is a small study intended to gather initial feasibility before conducting a larger study. The feasibility of using the Swiftsure CSS device will be studied among 20 patients at a single study site.
This is a prospective, single-center, single-arm, non-blinded trial to assess the feasibility of using the Swiftsure CSS device as an adjunct to the standard oral care among intubated adult patients undergoing mechanical ventilation in the ICU.
The CSS intervention will be performed 1 times per subject. The nurse performing the intervention will be asked to complete the study questionnaires after each device use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Treatment | Other | Treatment with the Swiftsure CSS device in addition to standard oral care procedures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swiftsure CCS device | Device | The Swiftsure CSS device will be used twice per patient in addition to standard oral health care procedures among intubated adult patients undergoing mechanical ventilation in the ICU. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success | Procedural success, defined as successful completion of the full procedure to use the Swiftsure CCS device, and standard oral care, | 1 to 4 hours post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of Swiftsure CCS device | The investigators will define success as an average score of neutral (i.e. 3) 1 is less or less success and 5 is best sucess, on a 5-point scale as measured by the Device Use Questionnaire | 1 to 4 hours post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcelo Gama de Abreu, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41123953 | Derived | Almeida VFA, Reuter Pimenta A, Lara-Erazo V, Karki D, Rodriguez-Patarroyo F, Semeia J, Duncan H, Filipovic N, Meyer D, Gama de Abreu M. Swiftsure complete care system in intubated adults: a feasibility study. Expert Rev Med Devices. 2025 Nov;22(11):1265-1270. doi: 10.1080/17434440.2025.2576586. Epub 2025 Oct 24. |
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Single arm study - treatment with the Swiftsure CSS device in addition to standard oral care procedures. Using a measuring scale of 1 to 5, for each patient, whereas 1 is low outcome of standard oral care and using the Swiftcare device, and 5 is best results for using standard oral care and the Swiftcare device.
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