A Pilot Study Swiftsure

Ventilated Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05578599
• Other study ID #: 22-554
• Status: Completed
• Phase: N/A
• Start date: October 12, 2022
• Est. completion date: March 10, 2023

Study information

• Verified date: March 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 10, 2023
• Est. primary completion date: February 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ventilated Patients

Intervention

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.

Locations

Country	Name	City	State
United States	The Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Usability of Swiftsure CCS device	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	1 to 4 hours post-procedure