A Pilot Study Swiftsure

Sponsor

The Cleveland Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05578599

Collaborator

(none)

Enrollment

Location

Arm

13.6

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventilated Patients	Device: Swiftsure CCS device	N/A

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 2 times per subject (over the course of 5-6 hours). The nurse performing the intervention will be asked to complete the study questionnaires after each device use.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

A Prospective, Single-center Clinical Pilot Study Evaluating Feasibility of the Swiftsure Complete Care System (CCS) in Intubated Adults Undergoing Mechanical Ventilation

Actual Study Start Date :

Oct 12, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Experimental Treatment Treatment with the Swiftsure CSS device in addition to standard oral care procedures	Device: Swiftsure 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.

Arm

Intervention/Treatment

Other: Experimental Treatment

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

Device: Swiftsure 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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Principal Investigator: Marcelo Gama de Abreu, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT05578599

Other Study ID Numbers:

22-554

First Posted:

Oct 13, 2022

Last Update Posted:

Feb 2, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Study Results

No Results Posted as of Feb 2, 2023