Implementation of CareCube Negative Pressure Isolation Units

NCT ID: NCT05229926

Last Updated: 2022-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-27

Study Completion Date

2021-03-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infectious Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient Group

Patients who previously were hospitalized during the COVID-19 pandemic, receiving mock care inside the CareCube

CareCube

Intervention Type DEVICE

modular, disposable, negative pressure, isolation patient care system

Patient Caregiver Group

Caregivers/family/friends of patients previously hospitalized during the COVID-19 pandemic, communicating with the patient inside the CareCube

No interventions assigned to this group

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.

No interventions assigned to this group

Interventions

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CareCube

modular, disposable, negative pressure, isolation patient care system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint Luke's Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32163699 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32427435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33353524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32362507 (View on PubMed)

Lenaghan PA, Schwedhelm M. Nebraska biocontainment unit design and operations. J Nurs Adm. 2015 Jun;45(6):298-301. doi: 10.1097/NNA.0000000000000202.

Reference Type BACKGROUND
PMID: 26010276 (View on PubMed)

Spielberger C, Gorsuch R, Lushene R, Vagg PR and Jacobs G. Manual for the State-Trait Anxiety Inventory (Form Y1 - Y2); 1983.

Reference Type 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.

Reference Type BACKGROUND
PMID: 17504886 (View on PubMed)

Pull CB. [DSM-IV]. Encephale. 1995 Dec;21 Spec No 5:15-20. French.

Reference Type BACKGROUND
PMID: 8582301 (View on PubMed)

Other Identifiers

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21-024

Identifier Type: -

Identifier Source: org_study_id

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