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Ambulatory Measurements of Physiological Parameters

Noninvasive Ambulatory Measurements of Physiological Parameters Using a DLS-based Sensor

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01267513
Acronym
LIFEBEAM
Enrollment
200
Registered
2010-12-28
Start date
2011-04-30
Completion date
2012-05-31
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Invasive Test of Pulse and Oxygen Saturation

Keywords

oxygen saturation, pulse rate, tachycardia, bradycardia, hypoxia

Brief 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. 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.

Interventions

None listed

Sponsors

Tel Aviv University
CollaboratorOTHER
Meir Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* Children * Patients unable or unwilling to give consent

Design outcomes

Primary

MeasureTime frameDescription
Comparison of oxygen saturation and pulse rate between our sensor and conventional sensors0ne yearWe wish to determine non-inferiority of our new sensor compared to current non-ambulatory sensors.

Countries

Israel

Contacts

Primary ContactLouis Shenkman, AB, MD
louissh@clalit.org.il+972-544-876600
Backup ContactSusy A Kovatz, MD
Susyk@clalit.org.il+972-544-972905

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026