A Pilot Study Swiftsure
Completed · Not applicable
Conditions studied: Ventilated Patients
In brief
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.
Key facts
- Study ID
- NCT05578599
- Run by
- The Cleveland Clinic
- People needed
- 22
- Starts
- 2022-10-12
- Expected to finish
- 2023-03-10
- Last updated by the study team
- 2023-03-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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