A Pilot Study Swiftsure

NeuroTherapia, Inc.

Status: Completed

Conditions: Ventilated Patients

Treatments: Device: Swiftsure CCS device

Study type: Interventional

Funder types: Other

Identifiers

NCT05578599

22-554

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Experimental Treatment

Other group

Description:

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

Treatment:

Device: Swiftsure CCS device