Implementation of CareCube Negative Pressure Isolation Units

Infectious Disease Clinical Trial

— CareCube  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05229926
• Other study ID #: 21-024
• Status: Completed
• Start date: March 27, 2021
• Est. completion date: March 27, 2021

Study information

• Verified date: January 2022
• Source: Saint Luke's Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 27, 2021
• Est. primary completion date: March 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Disease

Intervention

Device:
• CareCube
modular, disposable, negative pressure, isolation patient care system

Locations

Country	Name	City	State
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Saint Luke's Health System

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of Nursing Assistant Task - Nasal Swab	success of obtaining nasal swab as assessed by observer (successful/not successful)	through study completion, one day
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Completion of CRNA Task (Mannequin) - Intubation	success of intubation as assessed by observer (successful/not successful)	through study completion, one day
Primary	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	Caregiver Satisfaction	level of satisfaction based on completion of caregiver survey	through study completion, one day
Secondary	Healthcare Provider Satisfaction	level of satisfaction based on completion of provider survey	through study completion, one day
Secondary	Patient Experience of Claustrophobia	subject experience based on claustrophobia assessment	through study completion, one day
Secondary	Patient Experience of Stress and Anxiety	subject experience based on completion of STAIAD	through study completion, one day
Secondary	Patient Satisfaction	level of satisfaction based on completion of patient survey	through study completion, one day