Ambulatory Measurements of Physiological Parameters (LIFEBEAM)
Recruitment status was Recruiting
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.
Non Invasive Test of Pulse and Oxygen Saturation
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Noninvasive Ambulatory Measurements of Physiological Parameters Using a DLS-based Sensor|
- Comparison of oxygen saturation and pulse rate between our sensor and conventional sensors [ Time Frame: 0ne year ] [ Designated as safety issue: No ]We wish to determine non-inferiority of our new sensor compared to current non-ambulatory sensors.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||May 2012|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Normal individuals, aged 18 -75
Pulmonary and cardiac ICU, Trauma
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267513
|Contact: Louis Shenkman, AB, MDfirstname.lastname@example.org|
|Contact: Susy A Kovatz, MD||+972-544-972905||Susyk@clalit.org.il|
|Meir Medical Center||Recruiting|
|Kfar Saba, Israel, 44281|
|Contact: Louis Shenkman, AB, MD +972-544-876600 email@example.com|
|Principal Investigator:||Louis Shenkman, AB, MD||Meir Medicall Center|