Implementation of CareCube Negative Pressure Isolation Units

NCT05229926 | Completed

• 1 other identifier: 21-024
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious Disease

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (5)

• Caregiver Satisfaction

  through study completion, one day

• Healthcare Provider Satisfaction

  through study completion, one day

• Patient Experience of Claustrophobia

  through study completion, one day

• Patient Experience of Stress and Anxiety

  through study completion, one day

• Patient Satisfaction

  through study completion, one day

Study Arms (3)

Patient Group

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

Device: 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.

Interventions

CareCube DEVICE

modular, disposable, negative pressure, isolation patient care system

Patient Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Under 18 years of age
• Unable to provide written informed consent on own behalf

Sponsors & Collaborators

• Saint Luke's Health System: lead

Study Sites (1)

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Related Publications (8)

• 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.

  PMID: 32163699 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.

  PMID: 32427435 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.

  PMID: 33353524 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.

  PMID: 32362507 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.

  PMID: 26010276 BACKGROUND

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

  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.

  PMID: 17504886 BACKGROUND

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

  PMID: 8582301 BACKGROUND

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: February 8, 2022
• Study Start: March 27, 2021
• Primary Completion: March 27, 2021
• Study Completion: March 27, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)