Ambulatory Measurements of Physiological Parameters

NCT ID: NCT01267513

Last Updated: 2012-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-05-31

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.

Conditions

Non Invasive Test of Pulse and Oxygen Saturation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

normal volunteers

Normal individuals, aged 18 -75

No interventions assigned to this group

Hospitalized patients

Pulmonary and cardiac ICU, Trauma

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tel Aviv University

OTHER

Sponsor Role: collaborator

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louis Shenkman, AB, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medicall Center

Locations

Meir Medical Center

Kfar Saba, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Louis Shenkman, AB, MD

Role: CONTACT

louissh@clalit.org.il

+972-544-876600

Susy A Kovatz, MD

Role: CONTACT

Susyk@clalit.org.il

+972-544-972905

Facility Contacts

Louis Shenkman, AB, MD

Role: primary

louissh@clalit.org.il

+972-544-876600

References

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.

Reference Type: BACKGROUND

PMID: 19332258 (View on PubMed)

Other Identifiers

MMC202/2010

Identifier Type: OTHER

Identifier Source: secondary_id

Oxytone/Lifebeam Monitor

Identifier Type: -

Identifier Source: org_study_id