Implementation of CareCube Negative Pressure Isolation Units

Saint Luke's Health System

Status: Completed

Conditions: Infectious Disease

Treatments: Device: CareCube

Study type: Observational

Funder types: Other

Identifiers

NCT05229926

21-024

Details and patient eligibility

About

Pilot study to provide a descriptive analysis of the real-world feasibility of using a CareCube for COVID-19 patients in a high-volume tertiary care hospital.

Full description

The CareCube is a modular, disposable, negative pressure, isolation patient care system that can rapidly augment hospital's capacity to care for patients with contagious droplets or airborne pathogens. It is designed as a temporary single-use negative pressure isolation care unit with PPE for common patient care protocols built into the unit. The device is intended to be used in a healthcare setting as a temporary isolation of patients with suspected or confirmed diagnosis of COVID-19 to prevent Healthcare Practitioners (HCP) and patients' visitors from being exposed to pathogenic biological airborne particulates. The system includes three components: an isolation chamber, functional gown, and gloves. The isolation chamber functions in a similar manner to a hospital negative pressure, Airborne Infection Isolation Room. The gown and gloves provide an extra layer of barrier protection beyond PPE. The CareCube is designed to provide improved protection for front-line healthcare workers, while also conserving the vital supplies of N95 masks, face shields, and gowns, which are not required since there is no direct contact with the patient.

The goal of this project is to provide preliminary data to describe the experiences of 'patients', their caregivers, and providers with the CareCube.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult male or female previously hospitalized during the COVID-19 pandemic
• At least 21 days post- positive COVID-19 test result
• Able to provide written informed consent

Exclusion criteria

• Under 18 years of age
• Unable to provide written informed consent on own behalf

Trial design

16 participants in 3 patient groups

Patient Group

Description:

Patients who previously were hospitalized during the COVID-19 pandemic, receiving mock care inside the CareCube

Treatment:

Device: CareCube

Patient Caregiver Group

Description:

Caregivers/family/friends of patients previously hospitalized during the COVID-19 pandemic, communicating with the patient inside the CareCube

Heathcare Provider Group

Description:

Physicians, Certified Registered Nurse Anesthetists, RNs, Certified Nursing Assistants who will perform routine clinical care tasks, including passing food and medicines, drawing blood, inserting an IV. To simulate intubation, a mannequin will be used.