CCU InpatientsNCT04142073
CCU Wireless Vital Signs Monitoring
An observational study of CCU Inpatients, run by Northwestern University at 1 site in United States.
Trial summary
This is a pilot study is to test a wireless, skin-sensor device against current technology in the CCU to monitor vitals Read more about this study
- Who is it for?
- Ages 0 months to 18 years
- Conditions the study is for
- CCU Inpatients
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2019to 30 Jun 2023
- 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 0 months to 18 years
- All sexes
- Child, Adult
Study population: Patients under the age of eighteen admitted to the Lurie's Children's Cardiac Care Unit will be eligible to participate
Who may be able to join
- Patients under the age of eighteen admitted to the Lurie's Children's Cardiac Care Unit will be eligible to participate
Who cannot join
- Patients at imminent risk of death
- Patients with a skin abnormality that precludes assessment
- Patients with hyperbilirubinemia and requiring a need for UV light
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advanced Wireless and Wearable Sensors for Patients With Critical Neonatal and Pediatric Congenital Heart Defects
This is a pilot study is to test a wireless, skin-sensor device against current technology in the CCU to monitor vitals
Read the detailed description
This is a single center, prospective, observational study that will recruit subjects from Lurie Children's Hospital to test a wireless vitals monitor against the current vitals monitors used in the Cardiac Care Unit.
- Conditions
- CCU Inpatients
- Keywords
- wireless vitals, vitals monitor, cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children under 18 years of age | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent agreement with pilot sensor and current standard of vital signs monitoring
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start16 Apr 2019
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CCU InpatientsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Principal investigator, Stephanie Rangel, Northwestern University
- Investigators
- Stephanie Rangel, Study director, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142073
- Sponsor's protocol ID
- SX08072018
- Status last verified
- Jul 2023
- First submitted
- 25 Oct 2019
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Wireless and Wearable Sensors for Patients With Critical Neonatal and Pediatric Congenital Heart Defects
- ClinicalTrials.gov ID
- NCT04142073
- Acronym / sponsor ID
- SX08072018
- Conditions
- CCU Inpatients
- Keywords
- wireless vitals, vitals monitor, cardiac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 29 Oct 2019 (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 pilot study is to test a wireless, skin-sensor device against current technology in the CCU to monitor vitals
Detailed description
This is a single center, prospective, observational study that will recruit subjects from Lurie Children's Hospital to test a wireless vitals monitor against the current vitals monitors used in the Cardiac Care Unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children under 18 years of age | – | – |
Who may qualify
- Ages
- 0 months to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients under the age of eighteen admitted to the Lurie's Children's Cardiac Care Unit will be eligible to participate
Key inclusion criteria (1 listed)
- Patients under the age of eighteen admitted to the Lurie's Children's Cardiac Care Unit will be eligible to participate
Key exclusion criteria (3 listed)
- Patients at imminent risk of death
- Patients with a skin abnormality that precludes assessment
- Patients with hyperbilirubinemia and requiring a need for UV light
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent agreement with pilot sensor and current standard of vital signs monitoring
Time frame: 1 year
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 25 Jul 2023.
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.
Stephanie Rangel study director
Northwestern University
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 CCU Inpatients, run by Northwestern University 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 1 inclusion and 3 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 25 Jul 2023. 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?
Percent agreement with pilot sensor and current standard of vital signs monitoring (time frame: 1 year). 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 25 Jul 2023.