A Pilot Study Swiftsure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Single-center Clinical Pilot Study Evaluating Feasibility of the Swiftsure Complete Care System (CCS) in Intubated Adults Undergoing Mechanical Ventilation

Conditions
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Ventilated Patients

Intervention / Treatment
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* Device: Swiftsure CCS device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cardio-Vascular Intensive Care Unit (CVICU) patients recovering from surgery and expected to undergo mechanical ventilation for at least 6 hours 18 years or older Exclusion Criteria: Unable to consent Maxillofacial trauma Agitation Tested positive for COVID-19 at screening Any condition precluding positioning required for device use (e.g. increased intracranial pressure, spine instability, presence of spine drain etc) Oropharyngeal injury or infection Respiratory infection Difficult Airway Grade III or higher Intubated with a double lumen tube Tracheostomy Endotracheal tube cuff air leak, defined as inspiratory-to-expiratory tidal volume difference higher than 10% or audible gurgling at cuff pressure higher than 30 cmH2O Poor dental status Hemodynamic instability, defined as need for 2 or more vasopressor agents, or use of mechanical hemodynamic support (e.g. intra-aortic balloon pump, Impella heart pump, Left Ventricular Assist Device, venous- arterial extracorporeal membrane oxygenation) Respiratory instability, defined as PaO2/FIO2 < 300 mmHg on PEEP > 10 cmH2O, or respiratory acidosis with pHa < 7.30 and respiratory rate > 20, or use of inhaled pulmonary vasodilators Pregnancy or not using anti-conceptional agents in child bearing age Patients with difficult intubation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Experimental Treatment<br>Treatment with the Swiftsure CSS device in addition to standard oral care procedures | Device: Swiftsure CCS device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |