Clinical trial NCT05229926: Implementation of CareCube Negative Pressure Isolation Units
Official title: Implementation of CareCube Negative Pressure Isolation Units in a High-Volume Tertiary Care Hospital: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Disease
Lead sponsor: Saint Luke's Health System
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Completion of Nursing Assistant Task - Nasal Swab
timeFrame: through study completion, one day
measure: Completion of Nursing Assistant Task - Obtain Patient Weight
timeFrame: through study completion, one day
measure: Completion of Nursing Assistant Task - Obtain Vital Signs
timeFrame: through study completion, one day
measure: Completion of Nursing Assistant Task - Attach Telemetry Stickers
timeFrame: through study completion, one day
measure: Completion of Nursing Assistant Task - Place Nasal Cannula
timeFrame: through study completion, one day
measure: Completion of Nursing Assistant Task - Pass Through Tray
timeFrame: through study completion, one day
measure: Completion of Nursing Assistant Task - Receive Tray
timeFrame: through study completion, one day
measure: Completion of Registered Nurse Task - Medications
timeFrame: through study completion, one day
measure: Completion of Registered Nurse Task - Place Nasal Cannula
timeFrame: through study completion, one day
measure: Completion of Registered Nurse Task - Place Non-Rebreather Mask
timeFrame: through study completion, one day
measure: Completion of Registered Nurse Task - Place Intravenous Line
timeFrame: through study completion, one day
measure: Completion of CRNA Task (Mannequin) - Intubation
timeFrame: through study completion, one day
measure: Completion of CRNA Task (Mannequin) - Attach Defibrillator Pads
timeFrame: through study completion, one day
Secondary outcomes:
measure: Caregiver Satisfaction
timeFrame: through study completion, one day
measure: Healthcare Provider Satisfaction
timeFrame: through study completion, one day
measure: Patient Experience of Claustrophobia
timeFrame: through study completion, one day
measure: Patient Experience of Stress and Anxiety
timeFrame: through study completion, one day
measure: Patient Satisfaction
timeFrame: through study completion, one day
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
Study officials:
References:
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