Clinical trial NCT05468723: Evaluating Patient Comfort and Environmental Conditions in the Carecube Negative Pressure Isolation Chamber.1
Official title: Evaluating Patient Comfort and Environmental Conditions in the Carecube Negative Pressure Isolation Chamber.1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Diseases
Lead sponsor: Carecubes, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Nebraska
First posted: 2022-07-21
Enrollment: 11
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community members

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Temperature
timeFrame: 4 hours
measure: Blood Pressure
timeFrame: 4 hours
measure: Pulse
timeFrame: 4 hours
measure: Oxygen levels
timeFrame: 4 hours
measure: Movement
timeFrame: 4 hours
measure: Communication
timeFrame: 4 hours
measure: Environmental Condition
timeFrame: 4 hours
Secondary outcomes:
measure: Comfort
timeFrame: 4 hours
measure: Anxiety
timeFrame: 4 hours
Other outcomes:
Locations:
city: Omaha
country: United States
facility: UNMC
state: Nebraska
Study officials:
affiliation: UNMC
name: Andy Schnaubelt
role: PRINCIPAL_INVESTIGATOR
References: