Infectious DiseasesNCT05468723
Evaluating Patient Comfort and Environmental Conditions in the Carecube Negative Pressure Isolation Chamber.1
An observational study of Infectious Diseases, run by Carecubes, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Diseases
- What is being tested?
- Carecube Negative Pressure Isolation Chamber
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2022to 18 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community members
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Infectious Diseases
- Being tested
- Carecube Negative Pressure Isolation Chamber
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carecube Negative Pressure Isolation ChamberDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Temperature
Subject's body temperature maintains a normal healthy value based on their entry body temperature and outside the Carecube
Measured: 4 hours
Blood Pressure
Subject's blood pressure stays at a normal healthy level with respect to their initial baseline
Measured: 4 hours
Pulse
Subject's pulse stays within a normal healthy level based with respect to their initial baseline
Measured: 4 hours
Oxygen levels
Subject's Oxygen levels stays within a normal healthy level based with respect to their initial baseline
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 hours
Secondary outcomes (2)
Comfort
Subject does not become uncomfortable or claustrophobic
Measured: 4 hours
Anxiety
Subject does not become anxious
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start24 May 2022
- Primary completion18 Jun 2022
- Study completion18 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carecubes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Nebraska
- Responsible party
- Sponsor
- Investigators
- Andy Schnaubelt, Principal investigator, UNMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468723
- Sponsor's protocol ID
- TP-00003 Revision: 05
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Patient Comfort and Environmental Conditions in the Carecube Negative Pressure Isolation Chamber.1
- ClinicalTrials.gov ID
- NCT05468723
- Acronym / sponsor ID
- TP-00003 Revision: 05
- Conditions
- Infectious Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Carecubes, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Nebraska
- Study start
- 24 May 2022 (actual)
- Primary completion
- 18 Jun 2022 (actual)
- Study completion
- 18 Jun 2022 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community members
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carecube Negative Pressure Isolation ChamberSubjects 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. | Device | – |
Primary outcome
Body Temperature
Time frame: 4 hours
Subject's body temperature maintains a normal healthy value based on their entry body temperature and outside the Carecube
Blood Pressure
Time frame: 4 hours
Subject's blood pressure stays at a normal healthy level with respect to their initial baseline
Pulse
Time frame: 4 hours
Subject's pulse stays within a normal healthy level based with respect to their initial baseline
Oxygen levels
Time frame: 4 hours
Subject's Oxygen levels stays within a normal healthy level based with respect to their initial baseline
Movement
Time frame: 4 hours
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.
Communication
Time frame: 4 hours
Subject and provider are able to clearly and effectively communicate while the Subject is positioned within the Carecube Negative Pressure Isolation Chamber.
Environmental Condition
Time frame: 4 hours
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.
2 secondary outcomes
Comfort
Time frame: 4 hours
Anxiety
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andy Schnaubelt principal investigator
UNMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Diseases, run by Carecubes, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Temperature (time frame: 4 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.