Implementation of CareCube Negative Pressure Isolation Units (CareCube)

Implementation of CareCube Negative Pressure Isolation Units in a High-Volume Tertiary Care Hospital: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Infectious Disease
• Intervention / Treatment: Device: CareCube

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.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient Group; Patients who previously were hospitalized during the COVID-19 pandemic, receiving mock care inside the CareCube	Device: CareCube; 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Saint Luke's Health System

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Lenaghan PA, Schwedhelm M. Nebraska biocontainment unit design and operations. J Nurs Adm. 2015 Jun;45(6):298-301. doi: 10.1097/NNA.0000000000000202.
• Spielberger C, Gorsuch R, Lushene R, Vagg PR and Jacobs G. Manual for the State-Trait Anxiety Inventory (Form Y1 - Y2); 1983.
• 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.
• Pull CB. [DSM-IV]. Encephale. 1995 Dec;21 Spec No 5:15-20. French.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2021
• Primary Completion (Actual): March 27, 2021
• Study Completion (Actual): March 27, 2021

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 21-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No