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Completed

NCT Number: NCT05229926

Implementation of CareCube Negative Pressure Isolation Units

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CareCube

Device

modular, disposable, negative pressure, isolation patient care system

Primary outcomes

  1. Completion of Nursing Assistant Task - Nasal Swab

    Time frame: through study completion, one day

    success of obtaining nasal swab as assessed by observer (successful/not successful)

  2. Completion of Nursing Assistant Task - Obtain Patient Weight

    Time frame: through study completion, one day

    success of obtaining patient weight as assessed by observer (successful/not successful)

  3. Completion of Nursing Assistant Task - Obtain Vital Signs

    Time frame: through study completion, one day

    success of obtaining vital signs as assessed by observer (successful/not successful)

  4. Completion of Nursing Assistant Task - Attach Telemetry Stickers

    Time frame: through study completion, one day

    success of telemetry stickers attachment as assessed by observer (successful/not successful)

  5. Completion of Nursing Assistant Task - Place Nasal Cannula

    Time frame: through study completion, one day

    success of nasal cannula O2 placement as assessed by observer (successful/not successful)

  6. Completion of Nursing Assistant Task - Pass Through Tray

    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)

  7. Completion of Nursing Assistant Task - Receive Tray

    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)

  8. Completion of Registered Nurse Task - Medications

    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)

  9. Completion of Registered Nurse Task - Place Nasal Cannula

    Time frame: through study completion, one day

    success of nasal cannula O2 placement as assessed by observer (successful/not successful)

  10. Completion of Registered Nurse Task - Place Non-Rebreather Mask

    Time frame: through study completion, one day

    success of non-rebreather mask placement as assessed by observer (successful/not successful)

  11. Completion of Registered Nurse Task - Place Intravenous Line

    Time frame: through study completion, one day

    success of intravenous line placement as assessed by observer (successful/not successful)

  12. Completion of CRNA Task (Mannequin) - Intubation

    Time frame: through study completion, one day

    success of intubation as assessed by observer (successful/not successful)

  13. Completion of CRNA Task (Mannequin) - Attach Defibrillator Pads

    Time frame: through study completion, one day

    success of external defibrillator pad placement as assessed by observer (successful/not successful)

Secondary outcomes

  1. Caregiver Satisfaction

    Time frame: through study completion, one day

    level of satisfaction based on completion of caregiver survey

  2. Healthcare Provider Satisfaction

    Time frame: through study completion, one day

    level of satisfaction based on completion of provider survey

  3. Patient Experience of Claustrophobia

    Time frame: through study completion, one day

    subject experience based on claustrophobia assessment

  4. Patient Experience of Stress and Anxiety

    Time frame: through study completion, one day

    subject experience based on completion of STAIAD

  5. Patient Satisfaction

    Time frame: through study completion, one day

    level of satisfaction based on completion of patient survey

Sponsors and collaborators

Lead sponsor

Saint Luke's Health System

Other

Registry information

Official study title

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

Acronym: CareCube

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2022
Registry last updated
Feb 8, 2022

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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