Evaluating Patient Comfort and Environmental Conditions in the Carecube Negative Pressure Isolation Chamber.1
Condition: Infectious Diseases
MeSH terms: Communicable Diseases; Infections
Study type: Observational

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.
    

Intervention name(s): Carecube Negative Pressure Isolation Chamber
Intervention type(s): Device
Intervention description(s): 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.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community members