Clinical trial NCT01267513: Ambulatory Measurements of Physiological Parameters
Official title: Noninvasive Ambulatory Measurements of Physiological Parameters Using a DLS-based Sensor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Invasive Test of Pulse and Oxygen Saturation
Keywords: oxygen saturation
pulse rate
tachycardia
bradycardia
hypoxia
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2010-12-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of oxygen saturation and pulse rate between our sensor and conventional sensors
timeFrame: 0ne year
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medicall Center
name: Louis Shenkman, AB, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.