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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Group | Patients who previously were hospitalized during the COVID-19 pandemic, receiving mock care inside the CareCube |
| |
| Patient Caregiver Group | Caregivers/family/friends of patients previously hospitalized during the COVID-19 pandemic, communicating with the patient inside the CareCube | ||
| Heathcare Provider Group | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CareCube | Device | modular, disposable, negative pressure, isolation patient care system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion of Nursing Assistant Task - Nasal Swab | success of obtaining nasal swab as assessed by observer (successful/not successful) | through study completion, one day |
| Completion of Nursing Assistant Task - Obtain Patient Weight | success of obtaining patient weight as assessed by observer (successful/not successful) | through study completion, one day |
| Completion of Nursing Assistant Task - Obtain Vital Signs | success of obtaining vital signs as assessed by observer (successful/not successful) | through study completion, one day |
| Completion of Nursing Assistant Task - Attach Telemetry Stickers | success of telemetry stickers attachment as assessed by observer (successful/not successful) | through study completion, one day |
| Completion of Nursing Assistant Task - Place Nasal Cannula | success of nasal cannula O2 placement as assessed by observer (successful/not successful) | through study completion, one day |
| Completion of Nursing Assistant Task - Pass Through Tray | success of passing a tray of food via pass-through to patient as assessed by observer (successful/not successful) | through study completion, one day |
| Completion of Nursing Assistant Task - Receive Tray | success of collecting a tray of food/waste/ via pass-through from the patient as assessed by observer (successful/not successful) |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Satisfaction | level of satisfaction based on completion of caregiver survey | through study completion, one day |
| Healthcare Provider Satisfaction | level of satisfaction based on completion of provider survey |
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Inclusion Criteria:
Exclusion Criteria:
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Eight patients who previously were hospitalized during the COVID-19 pandemic, were approached for participation, along with their caregivers (family, friend or home nurse, who would regularly visit the patient in the hospital), if applicable. Patients were at least 21 days removed from a positive COVD-19 test, thus meeting and exceeding CDC guidelines for post COVID quarantine. Six healthcare providers (doctors, CRNAs, RNs, CNAs) were also recruited.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32163699 | Background | Jones DS. History in a Crisis - Lessons for Covid-19. N Engl J Med. 2020 Apr 30;382(18):1681-1683. doi: 10.1056/NEJMp2004361. Epub 2020 Mar 12. No abstract available. | |
| 32427435 | Background | Ortega R, Gonzalez M, Nozari A, Canelli R. Personal Protective Equipment and Covid-19. N Engl J Med. 2020 Jun 25;382(26):e105. doi: 10.1056/NEJMvcm2014809. Epub 2020 May 19. No abstract available. |
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No plan to share data
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| through study completion, one day |
| Completion of Registered Nurse Task - Medications | success of medicine reconciliation (generic medication questions, i.e., do you take an aspirin, etc.) with patient as assessed by observer (successful/not successful) | through study completion, one day |
| Completion of Registered Nurse Task - Place Nasal Cannula | success of nasal cannula O2 placement as assessed by observer (successful/not successful) | through study completion, one day |
| Completion of Registered Nurse Task - Place Non-Rebreather Mask | success of non-rebreather mask placement as assessed by observer (successful/not successful) | through study completion, one day |
| Completion of Registered Nurse Task - Place Intravenous Line | success of intravenous line placement as assessed by observer (successful/not successful) | through study completion, one day |
| Completion of CRNA Task (Mannequin) - Intubation | success of intubation as assessed by observer (successful/not successful) | through study completion, one day |
| Completion of CRNA Task (Mannequin) - Attach Defibrillator Pads | success of external defibrillator pad placement as assessed by observer (successful/not successful) | through study completion, one day |
| through study completion, one day |
| Patient Experience of Claustrophobia | subject experience based on claustrophobia assessment | through study completion, one day |
| Patient Experience of Stress and Anxiety | subject experience based on completion of STAIAD | through study completion, one day |
| Patient Satisfaction | level of satisfaction based on completion of patient survey | through study completion, one day |
| 33353524 | Background | Al-Benna S. Negative pressure rooms and COVID-19. J Perioper Pract. 2021 Jan-Feb;31(1-2):18-23. doi: 10.1177/1750458920949453. Epub 2020 Dec 1. |
| 32362507 | Background | Winck JC, Ambrosino N. COVID-19 pandemic and non invasive respiratory management: Every Goliath needs a David. An evidence based evaluation of problems. Pulmonology. 2020 Jul-Aug;26(4):213-220. doi: 10.1016/j.pulmoe.2020.04.013. Epub 2020 Apr 27. |
| 26010276 | Background | Lenaghan PA, Schwedhelm M. Nebraska biocontainment unit design and operations. J Nurs Adm. 2015 Jun;45(6):298-301. doi: 10.1097/NNA.0000000000000202. |
| Background | Spielberger C, Gorsuch R, Lushene R, Vagg PR and Jacobs G. Manual for the State-Trait Anxiety Inventory (Form Y1 - Y2); 1983. |
| 17504886 | Background | Vujanovic AA, Arrindell WA, Bernstein A, Norton PJ, Zvolensky MJ. Sixteen-item Anxiety Sensitivity Index: confirmatory factor analytic evidence, internal consistency, and construct validity in a young adult sample from the Netherlands. Assessment. 2007 Jun;14(2):129-43. doi: 10.1177/1073191106295053. |
| 8582301 | Background | Pull CB. [DSM-IV]. Encephale. 1995 Dec;21 Spec No 5:15-20. French. |