RespirationNCT01324817
Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates
An observational study of Respiration, run by Kai Medical, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to test the accuracy of two devices (the Kai Spot (v 2.1) and the Kai Continuous (v 1.0) that can measure breathing patters (how fast you breath) without wires and without touching the body. Read more about this study
- Who is it for?
- Ages Up to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiration
- What is being tested?
- Kai Spot (v 2.1) and Kai Continuous (v 1.0)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 2012
- 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 Up to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates hospitalized at the Kapiolani Medical Center for Women and Children located in Honolulu, HI
Who may be able to join
- 1. Clinically stable
Who cannot join
- 1. Clinically unstable
- Hypotensive requiring pressors
- Intubated
- 2. Scheduled or planned (e.g., CT scan, central line placement) procedure during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Annette Amiotte, RN, BSN, 808-983-6386, aamiotte@kapiolani.org
Venkataraman Balaraman, MD
About this study
The purpose of this study is to test the accuracy of two devices (the Kai Spot (v 2.1) and the Kai Continuous (v 1.0) that can measure breathing patters (how fast you breath) without wires and without touching the body.
Read the detailed description
The purpose of this study is to test two remote, Doppler radar-based sensors to measure and monitor respiratory rate. Specifically, in clinically stable neonatal patients the study aims to:
- Obtain respiratory effort data of neonatal patients with remote Doppler radar systems modified from a system cleared by the FDA for adult use.
- Determine if remote Doppler radar systems can accurately detect the respiratory rate of neonatal patients, compared with standard measurement systems.
- Determine if unattended Doppler radar systems, operating for 4 hours, can accurately detect the respiratory rate of neonatal patients.
- Conditions
- Respiration
- Being tested
- Kai Spot (v 2.1), Kai Continuous (v 1.0)
- Keywords
- Non-Contact, Radar, Doppler, Respiratory, Respiration, Breathing, Rate, Frequency, Respiratory Mechanics, Respiratory Rate Measurement, Apnea, Sleep Apnea
- Medical subject headings
- Respiratory Aspiration, Apnea, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kai Spot (v 2.1)Device
Also called Kai Spot
The Kai Spot (v 2.1) provides a measurement of respiratory rate at a single point in time for neonates, pediatrics, and adults.
Kai Continuous (v 1.0)Device
Also called Kai Continuous
The Kai Continuous (v 1.0) provides a continuous monitor, measurement, and display of the respiratory rate, respiratory patterns, depth of breath, history/events and respiratory activity of a subject for neonates, pediatrics, and adults.
| Study group | Role | What they receive |
|---|---|---|
| Hopitalized | Patients admitted to the hospital Receives: Device: Kai Spot (v 2.1); Device: Kai Continuous (v 1.0) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RespirationStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kai Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Venkataraman Balaraman, MD, Principal investigator, Kapiolani Medical Center For Women & Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324817
- Sponsor's protocol ID
- KAI-00006
- Status last verified
- Dec 2011
- First submitted
- 26 Mar 2011
- Last updated
- 14 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates
- ClinicalTrials.gov ID
- NCT01324817
- Acronym / sponsor ID
- KAI-00006
- Conditions
- Respiration
- Keywords
- Non-Contact, Radar, Doppler, Respiratory, Respiration, Breathing, Rate, Frequency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kai Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 29 Mar 2011 (estimated)
- 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.
The purpose of this study is to test the accuracy of two devices (the Kai Spot (v 2.1) and the Kai Continuous (v 1.0) that can measure breathing patters (how fast you breath) without wires and without touching the body.
Detailed description
The purpose of this study is to test two remote, Doppler radar-based sensors to measure and monitor respiratory rate. Specifically, in clinically stable neonatal patients the study aims to:
- Obtain respiratory effort data of neonatal patients with remote Doppler radar systems modified from a system cleared by the FDA for adult use.
- Determine if remote Doppler radar systems can accurately detect the respiratory rate of neonatal patients, compared with standard measurement systems.
- Determine if unattended Doppler radar systems, operating for 4 hours, can accurately detect the respiratory rate of neonatal patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hopitalized | – | Device: Kai Spot (v 2.1), Device: Kai Continuous (v 1.0)Patients admitted to the hospital |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates hospitalized at the Kapiolani Medical Center for Women and Children located in Honolulu, HI
Key inclusion criteria (1 listed)
- 1. Clinically stable
Key exclusion criteria (4 listed)
- 1. Clinically unstable
- Hypotensive requiring pressors
- Intubated
- 2. Scheduled or planned (e.g., CT scan, central line placement) procedure during the study period.
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 |
|---|---|---|
| Kai Spot (v 2.1)Also: Kai SpotThe Kai Spot (v 2.1) provides a measurement of respiratory rate at a single point in time for neonates, pediatrics, and adults. | Device | Hopitalized |
| Kai Continuous (v 1.0)Also: Kai ContinuousThe Kai Continuous (v 1.0) provides a continuous monitor, measurement, and display of the respiratory rate, respiratory patterns, depth of breath, history/events and respiratory activity of a subject for neonates, pediatrics, and adults. | Device | Hopitalized |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2011.
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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.
Venkataraman Balaraman, MD principal investigator
Kapiolani Medical Center For Women & Children
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 Respiration, run by Kai Medical, 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Dec 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Venkataraman Balaraman, MD (808-983-6718, VBalaraman@kapiolani.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 14 Dec 2011.