A Pilot Study Swiftsure

Not Applicable

Completed

• Conditions: Ventilated Patients
• Interventions: Device: Swiftsure CCS device

• Registration Number: NCT05578599
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-10-10
• Study Start: 2022-10-12
• Study First Posted: 2022-10-13
• Primary Completion: 2023-02-16
• Status Verified: 2023-03
• Study Completion: 2023-03-10
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Treatment	Swiftsure CCS device	Treatment with the Swiftsure CSS device in addition to standard oral care procedures

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States