Evaluating Patient Comfort and Environmental Conditions in the Carecube Negative Pressure Isolation Chamber.1

Infectious Diseases Clinical Trial

Official title:

Evaluating Patient Comfort and Environmental Conditions in the Carecube Negative Pressure Isolation Chamber.1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05468723
• Other study ID #: TP-00003 Revision: 05
• Status: Completed
• Start date: May 24, 2022
• Est. completion date: June 18, 2022

Study information

• Verified date: July 2022
• Source: Carecubes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a human non-significant risk (NSR) clinical study designed to objectively and participatively verify that the Carecube Negative Pressure Isolation Chamber is a safe and non-hostile environment for the patients that will be contained within the chamber during normal operations.

Description:

Device Information:

The Carecube Negative Pressure Isolation Chamber is a patient isolation unit (PIU) designed for the temporary isolation of patients within a hospital to prevent particulate (biological) cross-contamination between user and patient, while enclosing the contaminated patient from the external environment.

Study Description:

Participants will be tasked to stay within the Carecube Negative Pressure Isolation Chamber for a minimum of three consecutive time points (1 hour apart) illustrating a plateau level for all parameters, up to a maximum of 7 hours (readings will be taken at baseline and hourly thereafter).

The Carecube Negative Pressure Isolation Chamber will be set up indoors, in an emergency department and hospital floor environment. We will collect data and demonstrate that the Carecube Isolation chamber is a safe and non-hostile environment for the patients that will be contained within, during normal operations.

Each participant will be asked to come to a test center facility to complete and sign the informed consent and receive instruction to interact with the simulation. Subjects will be tasked to stay within the Carecube Isolation Chamber for at least 4 hours and have 3 consecutive timepoints illustrating a plateau level for all participants parameters.

Environmental data will be collected by physicians and nurses. Additionally, atmospheric Oxygen, Carbon Dioxide, humidity, and room temperature will be monitored and recorded. External to the room humidity and temperatures will also be recorded. The participant will be exposed to room temperature (° Fahrenheit) and humidity (RH%), ranging from 65°- 90° Fahrenheit and 30%-60% RH. Participants will also be asked to record on a questionnaire, in order to demonstrate that the Carecube Negative Pressure Isolation chamber is a safe and non-hostile environment for the patients that will be contained during normal operations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 18, 2022
• Est. primary completion date: June 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

Inclusion Criteria:

Male, female, non-binary between the ages of 19-65 No existing medical condition that would impact the Subject from staying within the containment system for the specified time-period.

Patient is not pre-dispositioned for claustrophobia

Exclusion Criteria:

Subjects that have a pre-existing condition of claustrophobia Subjects that have a history of hypertension Subjects with a clinical diagnosis of generalized anxiety disorder (GAD) Subjects with a clinical diagnosis of major depressive disorder (MDD) Morbidly obese patients (BMI above 40) Subjects who are Women of Child Bearing Potential (WOCBP) who either are pregnant or suspect they are pregnant

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Diseases

Intervention

Device:
• Carecube Negative Pressure Isolation Chamber
Subjects will be tasked to stay within the Carecube Isolation Chamber for at least 4 hours and have 3 consecutive timepoints illustrating a plateau level for all participants parameters. Environmental data will be collected by physicians and nurses [which may include physicians, physician assistants, Registered Nurses, Licensed Practical Nurses, medical technicians and emergency medical technicians (EMTs)] . Additionally, atmospheric Oxygen, Carbon Dioxide, humidity, and room temperature will be monitored and recorded on an hourly basis. External to the room humidity and temperatures will also be recorded. The participant will be exposed to room temperature (° Fahrenheit) and humidity (RH%), ranging from 65°- 90° Fahrenheit and 30%-60% RH. Participants will also be asked to record on a questionnaire, in order to demonstrate that the Carecube Negative Pressure Isolation chamber is a safe and non-hostile environment for the patients that will be contained during normal operations.

Locations

Country	Name	City	State
United States	UNMC	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Carecubes, Inc.	University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Temperature	Subject's body temperature maintains a normal healthy value based on their entry body temperature and outside the Carecube	4 hours
Primary	Blood Pressure	Subject's blood pressure stays at a normal healthy level with respect to their initial baseline	4 hours
Primary	Pulse	Subject's pulse stays within a normal healthy level based with respect to their initial baseline	4 hours
Primary	Oxygen levels	Subject's Oxygen levels stays within a normal healthy level based with respect to their initial baseline	4 hours
Primary	Movement	Subject is able to move within the Carecube, to include activities such as sitting up, laying down, rotating, foot flexion or other body positioning within the hospital bed located within the Carecube.	4 hours
Primary	Communication	Subject and provider are able to clearly and effectively communicate while the Subject is positioned within the Carecube Negative Pressure Isolation Chamber.	4 hours
Primary	Environmental Condition	Environment does not have an elevation of temperature, Carbon Dioxide and humidity outside a normal range as compared to the external environment of the chamber.	4 hours
Secondary	Comfort	Subject does not become uncomfortable or claustrophobic	4 hours
Secondary	Anxiety	Subject does not become anxious	4 hours