Non Invasive Test of Pulse and Oxygen SaturationLIFEBEAMNCT01267513
Ambulatory Measurements of Physiological Parameters
An observational study of Non Invasive Test of Pulse and Oxygen Saturation, run by Meir Medical Center at 1 site in Israel.
Trial summary
Ambulatory monitoring of physiological variables is important in following the health status of individuals in non-hospital controlled situations. The investigators are developing a non-invasive sensor based on dynamic light scattering that is able to measure pulse, blood flow and coagulability. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Invasive Test of Pulse and Oxygen Saturation
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to May 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal volunteers will be studied. Individuals undergoing routine cardiac stress testing will be studied. Stable patients admitted to the pulmanary ward who are being monitored routinely for oxygen saturation and pulse will be studied.
Who may be able to join
- Patients who are able to sign informed consent.
- Patients undergoing standard cardiac stress tests who are able to sign informed consent.
- Patients with pulmonary disease who are being monitored in a routine manner who are will ing to sign informed consent.
Who cannot join
- Children
- Patients unable or unwilling to give consent
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba, 44281
Louis Shenkman, AB, MD, +972-544-876600, louissh@clalit.org.il
About this study
Official title: Noninvasive Ambulatory Measurements of Physiological Parameters Using a DLS-based Sensor
Ambulatory monitoring of physiological variables is important in following the health status of individuals in non-hospital controlled situations. The investigators are developing a non-invasive sensor based on dynamic light scattering that is able to measure pulse, blood flow and coagulability. Oxygen saturation can also be detected with minor modification of the apparatus. The investigators plan to validate the investigators sensor by applying it to patients in the intensive care unit, or to patients undergoing cardiac stress tests. The results of the investigators sensor will not be utilized for any therapeutic decisions, but will be collected for later comparison with conventional monitoring of pulse and oxygenation with standard monitors. The monitor is worn like a wrist watch, and will collect data into a small data storage disc for later analysis.
Read the detailed description
Subjects to be studied will be either individuals undergoing routine cardiac stress tests, or patients admitted to the pulmonary ward of Meir Hospital who are being monitored in conventional manner. Normal volunteers will also be tested, under the following conditions: at rest, while running, while performing calisthenics, and while crawling on the ground. If non-inferiority of the new sensor is established compared to the standard clinically used sensors, then additional studies will be performed on acutely ill patients, such as patients admitted with multi-trauma.
- Keywords
- oxygen saturation, pulse rate, tachycardia, bradycardia, hypoxia
- Medical subject headings
- Tachycardia, Bradycardia, Hypoxia
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 |
|---|---|---|
| normal volunteers | Normal individuals, aged 18 -75 | |
| Hospitalized patients | Pulmonary and cardiac ICU, Trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of oxygen saturation and pulse rate between our sensor and conventional sensors
We wish to determine non-inferiority of our new sensor compared to current non-ambulatory sensors.
Measured: 0ne year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startApr 2011
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Invasive Test of Pulse and Oxygen SaturationStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
- Investigators
- Louis Shenkman, AB, MD, Principal investigator, Meir Medicall Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267513
- Sponsor's protocol ID
- Oxytone/Lifebeam Monitor
- Other IDs
- MMC202/2010
- Acronym
- LIFEBEAM
- Status last verified
- Mar 2012
- First submitted
- 27 Dec 2010
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shitrit D, Rusanov V, Peled N, Amital A, Fuks L, Kramer MR. The 15-step oximetry test: a reliable tool to identify candidates for lung transplantation among patients with idiopathic pulmonary fibrosis. J Heart Lung Transplant. 2009 Apr;28(4):328-33. doi: 10.1016/j.healun.2008.12.019.
PubMed 19332258
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Ambulatory Measurements of Physiological Parameters Using a DLS-based Sensor
- ClinicalTrials.gov ID
- NCT01267513
- Acronym / sponsor ID
- LIFEBEAM / Oxytone/Lifebeam Monitor
- Keywords
- oxygen saturation, pulse rate, tachycardia, bradycardia, hypoxia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- Apr 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 28 Dec 2010 (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.
Ambulatory monitoring of physiological variables is important in following the health status of individuals in non-hospital controlled situations. The investigators are developing a non-invasive sensor based on dynamic light scattering that is able to measure pulse, blood flow and coagulability. Oxygen saturation can also be detected with minor modification of the apparatus. The investigators plan to validate the investigators sensor by applying it to patients in the intensive care unit, or to patients undergoing cardiac stress tests. The results of the investigators sensor will not be utilized for any therapeutic decisions, but will be collected for later comparison with conventional monitoring of pulse and oxygenation with standard monitors. The monitor is worn like a wrist watch, and will collect data into a small data storage disc for later analysis.
Detailed description
Subjects to be studied will be either individuals undergoing routine cardiac stress tests, or patients admitted to the pulmonary ward of Meir Hospital who are being monitored in conventional manner. Normal volunteers will also be tested, under the following conditions: at rest, while running, while performing calisthenics, and while crawling on the ground. If non-inferiority of the new sensor is established compared to the standard clinically used sensors, then additional studies will be performed on acutely ill patients, such as patients admitted with multi-trauma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal volunteers | – | –Normal individuals, aged 18 -75 |
| Hospitalized patients | – | –Pulmonary and cardiac ICU, Trauma |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal volunteers will be studied. Individuals undergoing routine cardiac stress testing will be studied. Stable patients admitted to the pulmanary ward who are being monitored routinely for oxygen saturation and pulse will be studied.
Key inclusion criteria (3 listed)
- Patients who are able to sign informed consent.
- Patients undergoing standard cardiac stress tests who are able to sign informed consent.
- Patients with pulmonary disease who are being monitored in a routine manner who are will ing to sign informed consent.
Key exclusion criteria (2 listed)
- Children
- Patients unable or unwilling to give consent
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
Comparison of oxygen saturation and pulse rate between our sensor and conventional sensors
Time frame: 0ne year
We wish to determine non-inferiority of our new sensor compared to current non-ambulatory sensors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
- Background: PubMed 19332258Shitrit D, Rusanov V, Peled N, Amital A, Fuks L, Kramer MR. The 15-step oximetry test: a reliable tool to identify candidates for lung transplantation among patients with idiopathic pulmonary fibrosis. J Heart Lung Transplant. 2009 Apr;28(4):328-33. doi: 10.1016/j.healun.2008.12.019.
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.
Louis Shenkman, AB, MD principal investigator
Meir Medicall Center
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 Non Invasive Test of Pulse and Oxygen Saturation, run by Meir Medical Center at 1 site in Israel.
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 3 inclusion and 2 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 19 Mar 2012. 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 Israel. 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 Louis Shenkman, AB, MD (+972-544-876600, louissh@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of oxygen saturation and pulse rate between our sensor and conventional sensors (time frame: 0ne year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01267513, which also lists 1 linked publication.
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 19 Mar 2012.