A Pilot Study Swiftsure

NCT05578599 | Completed FDA Device

• 1 other identifier: 22-554
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilated Patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Usability of Swiftsure CCS device

  1 to 4 hours post-procedure

Study Arms (1)

Experimental Treatment

OTHER

Treatment with the Swiftsure CSS device in addition to standard oral care procedures

Device: Swiftsure CCS device

Interventions

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.

Experimental Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 41123953 DERIVED

Study Officials

• Marcelo Gama de Abreu, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 13, 2022
• Study Start: October 12, 2022
• Primary Completion: February 16, 2023
• Study Completion: March 10, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)