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| ID | Type | Description | Link |
|---|---|---|---|
| MMC202/2010 | Other Identifier | Meir Hospital Center, Kfar Saba, Israel |
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| Name | Class |
|---|---|
| Tel Aviv University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normal volunteers | Normal individuals, aged 18 -75 | ||
| Hospitalized patients | Pulmonary and cardiac ICU, Trauma |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0ne year |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louis Shenkman, AB, MD | Contact | +972-544-876600 | louissh@clalit.org.il | |
| Susy A Kovatz, MD | Contact | +972-544-972905 | Susyk@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Louis Shenkman, AB, MD | Meir Medicall Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Recruiting | Kfar Saba | 44281 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19332258 | Background | 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. |
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| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001919 | Bradycardia |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |