Infectious Disease
Conditions
Brief summary
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.
Detailed 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.
Interventions
DEVICECareCube
modular, disposable, negative pressure, isolation patient care system
Sponsors
Saint Luke's Health System
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of CRNA Task (Mannequin) - Attach Defibrillator Pads | through study completion, one day | success of external defibrillator pad placement as assessed by observer (successful/not successful) |
| Completion of Registered Nurse Task - Medications | through study completion, one day | success of medicine reconciliation (generic medication questions, i.e., do you take an aspirin, etc.) with patient as assessed by observer (successful/not successful) |
| Completion of Registered Nurse Task - Place Nasal Cannula | through study completion, one day | success of nasal cannula O2 placement as assessed by observer (successful/not successful) |
| Completion of Registered Nurse Task - Place Non-Rebreather Mask | through study completion, one day | success of non-rebreather mask placement as assessed by observer (successful/not successful) |
| Completion of Registered Nurse Task - Place Intravenous Line | through study completion, one day | success of intravenous line placement as assessed by observer (successful/not successful) |
| Completion of CRNA Task (Mannequin) - Intubation | through study completion, one day | success of intubation as assessed by observer (successful/not successful) |
| Completion of Nursing Assistant Task - Nasal Swab | through study completion, one day | success of obtaining nasal swab as assessed by observer (successful/not successful) |
| Completion of Nursing Assistant Task - Obtain Patient Weight | through study completion, one day | success of obtaining patient weight as assessed by observer (successful/not successful) |
| Completion of Nursing Assistant Task - Obtain Vital Signs | through study completion, one day | success of obtaining vital signs as assessed by observer (successful/not successful) |
| Completion of Nursing Assistant Task - Attach Telemetry Stickers | through study completion, one day | success of telemetry stickers attachment as assessed by observer (successful/not successful) |
| Completion of Nursing Assistant Task - Place Nasal Cannula | through study completion, one day | success of nasal cannula O2 placement as assessed by observer (successful/not successful) |
| Completion of Nursing Assistant Task - Pass Through Tray | through study completion, one day | success of passing a tray of food via pass-through to patient as assessed by observer (successful/not successful) |
| Completion of Nursing Assistant Task - Receive Tray | through study completion, one day | success of collecting a tray of food/waste/ via pass-through from the patient as assessed by observer (successful/not successful) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Provider Satisfaction | through study completion, one day | level of satisfaction based on completion of provider survey |
| Patient Experience of Claustrophobia | through study completion, one day | subject experience based on claustrophobia assessment |
| Patient Experience of Stress and Anxiety | through study completion, one day | subject experience based on completion of STAIAD |
| Patient Satisfaction | through study completion, one day | level of satisfaction based on completion of patient survey |
| Caregiver Satisfaction | through study completion, one day | level of satisfaction based on completion of caregiver survey |
Countries
United States
Outcome results
None listed