Clinical trial NCT05578599: A Pilot Study Swiftsure
Official title: A Prospective, Single-center Clinical Pilot Study Evaluating Feasibility of the Swiftsure Complete Care System (CCS) in Intubated Adults Undergoing Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilated Patients
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Procedural success
timeFrame: 1 to 4 hours post-procedure
Secondary outcomes:
measure: Usability of Swiftsure CCS device
timeFrame: 1 to 4 hours post-procedure
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Marcelo Gama de Abreu, MD
role: PRINCIPAL_INVESTIGATOR
References: