Ambulatory Measurements of Physiological Parameters

Non Invasive Test of Pulse and Oxygen Saturation Clinical Trial

— LIFEBEAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01267513
• Other study ID #: Oxytone/Lifebeam Monitor
• Secondary ID: MMC202/2010
• Status: Recruiting
• Phase: N/A
• First received: December 27, 2010
• Last updated: March 16, 2012
• Start date: April 2011
• Est. completion date: May 2012

Study information

• Verified date: March 2012
• Source: Meir Medical Center
• Contact: Louis Shenkman, AB, MD
• Phone: +972-544-876600
• Email: louissh[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Non Invasive Test of Pulse and Oxygen Saturation

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (2)

Lead Sponsor	Collaborator
Meir Medical Center	Tel Aviv University

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No