Ventilated Patients
Conditions
Brief summary
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
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.
Interventions
DEVICESwiftsure CCS 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.
Sponsors
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | 1 to 4 hours post-procedure | Procedural success, defined as successful completion of the full procedure to use the Swiftsure CCS device, and standard oral care, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability of Swiftsure CCS device | 1 to 4 hours post-procedure | 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 |
Countries
United States
Outcome results
None listed