Ambulatory Measurements of Physiological Parameters (LIFEBEAM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01267513
First received: December 27, 2010
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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.


Condition
Non Invasive Test of Pulse and Oxygen Saturation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Noninvasive Ambulatory Measurements of Physiological Parameters Using a DLS-based Sensor

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 200
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)
Groups/Cohorts
normal volunteers
Normal individuals, aged 18 -75
Hospitalized patients
Pulmonary and cardiac ICU, Trauma

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267513

Contacts
Contact: Louis Shenkman, AB, MD +972-544-876600 louissh@clalit.org.il
Contact: Susy A Kovatz, MD +972-544-972905 Susyk@clalit.org.il

Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Contact: Louis Shenkman, AB, MD    +972-544-876600    louissh@clalit.org.il   
Sponsors and Collaborators
Meir Medical Center
Tel Aviv University
Investigators
Principal Investigator: Louis Shenkman, AB, MD Meir Medicall Center
  More Information

Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01267513     History of Changes
Other Study ID Numbers: Oxytone/Lifebeam Monitor, MMC202/2010
Study First Received: December 27, 2010
Last Updated: March 16, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
oxygen saturation
pulse rate
tachycardia
bradycardia
hypoxia

ClinicalTrials.gov processed this record on September 18, 2014