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

NCT05468723 | Completed FDA Device

• 1 other identifier: TP-00003 Revision: 05
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious Diseases

Outcome Measures

Primary Outcomes (7)

• Body Temperature

  Subject's body temperature maintains a normal healthy value based on their entry body temperature and outside the Carecube

  4 hours

• Blood Pressure

  Subject's blood pressure stays at a normal healthy level with respect to their initial baseline

  4 hours

• Pulse

  Subject's pulse stays within a normal healthy level based with respect to their initial baseline

  4 hours

• Oxygen levels

  Subject's Oxygen levels stays within a normal healthy level based with respect to their initial baseline

  4 hours

• 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

• 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

• 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 Outcomes (2)

• Comfort

  4 hours

• Anxiety

  4 hours

Interventions

Carecube Negative Pressure Isolation Chamber DEVICE

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.

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community members

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carecubes, Inc.: lead
• University of Nebraska: collaborator

Study Sites (1)

UNMC

Omaha, Nebraska, 68198-8437, United States

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andy Schnaubelt

  UNMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 21, 2022
• Study Start: May 24, 2022
• Primary Completion: June 18, 2022
• Study Completion: June 18, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

US (1)