Implementation of CareCube Negative Pressure Isolation Units
- Conditions
- Infectious Disease
- Interventions
- Device: CareCube
- Registration Number
- NCT05229926
- Lead Sponsor
- Saint Luke's Health System
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- Under 18 years of age
- Unable to provide written informed consent on own behalf
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient Group CareCube Patients who previously were hospitalized during the COVID-19 pandemic, receiving mock care inside the CareCube
- Primary Outcome Measures
Name Time Method 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)
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 CRNA Task (Mannequin) - Attach Defibrillator Pads through study completion, one day success of external defibrillator pad placement as assessed by observer (successful/not successful)
- Secondary Outcome Measures
Name Time Method Caregiver Satisfaction through study completion, one day level of satisfaction based on completion of caregiver survey
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
Trial Locations
- Locations (1)
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States