Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
NCT Number: NCT05229926
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.
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Notify Me18 year and older
All sexes
Observational
Kansas City, Missouri, 64111, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
modular, disposable, negative pressure, isolation patient care system
Time frame: through study completion, one day
success of obtaining nasal swab as assessed by observer (successful/not successful)
Time frame: through study completion, one day
success of obtaining patient weight as assessed by observer (successful/not successful)
Time frame: through study completion, one day
success of obtaining vital signs as assessed by observer (successful/not successful)
Time frame: through study completion, one day
success of telemetry stickers attachment as assessed by observer (successful/not successful)
Time frame: through study completion, one day
success of nasal cannula O2 placement as assessed by observer (successful/not successful)
Time frame: through study completion, one day
success of passing a tray of food via pass-through to patient as assessed by observer (successful/not successful)
Time frame: 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)
Time frame: 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)
Time frame: through study completion, one day
success of nasal cannula O2 placement as assessed by observer (successful/not successful)
Time frame: through study completion, one day
success of non-rebreather mask placement as assessed by observer (successful/not successful)
Time frame: through study completion, one day
success of intravenous line placement as assessed by observer (successful/not successful)
Time frame: through study completion, one day
success of intubation as assessed by observer (successful/not successful)
Time frame: through study completion, one day
success of external defibrillator pad placement as assessed by observer (successful/not successful)
Time frame: through study completion, one day
level of satisfaction based on completion of caregiver survey
Time frame: through study completion, one day
level of satisfaction based on completion of provider survey
Time frame: through study completion, one day
subject experience based on claustrophobia assessment
Time frame: through study completion, one day
subject experience based on completion of STAIAD
Time frame: through study completion, one day
level of satisfaction based on completion of patient survey
Saint Luke's Health System
Other
Implementation of CareCube Negative Pressure Isolation Units in a High-Volume Tertiary Care Hospital: A Pilot Study
Acronym: CareCube
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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