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Trial record 6 of 619 for:    oximeter

A Clinical Evaluation of the Oxitone Non-invasive Oximeter (CPOM)

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ClinicalTrials.gov Identifier: NCT02658045
Recruitment Status : Unknown
Verified November 2015 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 18, 2016
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:

The trial shall assess the accuracy of the Oxitone® 1000 in measuring oxygen saturation, by comparing its measurement to reference devices: non-invasive SpO2 and pulse-rate values determined by a pulse oximeter. A total of approximately 40 subjects: 20 healthy and 20 COPD (chronic obstructive pulmonary disease ) patients will be enrolled. These subjects will be enrolled at the medical center pulmonary department and will be recruited from the clinic patient base. The subjects will be represented by male and female adults who optimally cover a range of ethnic backgrounds (skin pigmentation). All testing will be performed in singleton and in a blinded fashion. This study will be conducted with the approval of the medical center ethics committee.

This is a comparison open study with no subject follow-up.


Condition or disease Intervention/treatment
COPD Chronic Lung Disease Device: Standard Oximeter Device: Oxitone oximeter

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Evaluation of the Oxitone Non-invasive Oximeter. Method Comparison Study vs. a Standard Clinical Pulse-oximeter Monitor. A Prospective Open Study
Study Start Date : February 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Group/Cohort Intervention/treatment
Normal healthy volunteers
Measurement of oxygen saturation simultaneously by standard oximeter and Oxitone oximeter in healthy volunteers during 6 min walking test
Device: Standard Oximeter
Oxygen saturation will be measured by standard oximeter

Device: Oxitone oximeter
Oxygen saturation will be measured by Oxitone oximeter

COPD patients
Measurement of oxygen saturation simultaneously by standard oximeter and Oxitone oximeter in COPD patients during 6 min walking test
Device: Standard Oximeter
Oxygen saturation will be measured by standard oximeter

Device: Oxitone oximeter
Oxygen saturation will be measured by Oxitone oximeter




Primary Outcome Measures :
  1. change in oxygen saturation from baseline to six minute walk [ Time Frame: Baseline and after six minute walk ]
    Oxygen saturation is measured with standard oximeter and Oxitone oximeter



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Approximately 30 subjects will be recruited. Participants will be screened for inclusion/exclusion criteria at enrolment and will be asked to sign an informed consent form. Only those who give written informed consent will be included in the study. Basic clinical, demographic including skin type (Fitzpatrick scale) information and past medical history (CRF) will be recorded.

Patient selection: Adult patients over the age of 18 of both genders will be recruited. Patients will be either outpatients in the pulmonary department, or ambulatory patients undergoing rehabilitation.

Normal Healthy volunteers will be recruited from hospital personnel or medical students. There will be no known additional risk for the subjects.

Criteria

Inclusion Criteria:

  • Pulmonary sick and healthy male and female volunteers aged 18 years and over (any race or ethnicity).
  • Subjects who are willing to give informed consent.
  • No precautions are required: this study involves no known additional risk to the subjects.

Exclusion Criteria:

  • Participants under the age of 18 years
  • Significant deformity, degenerative changes or edema of the hand wrist
  • Localized infection, ulceration or skin breaks involving the wrist
  • Vascular disease or Raynaud's phenomenon affecting the hand
  • Participants who are unable to give informed written consent
  • Anemia: Hb < 10.0 g/dl

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658045


Contacts
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Contact: Alex - Guber, MD +972-522-496934 Alexgu@clalit.org.il
Contact: Louis - Shenkman, MD +972-544-876600 lshenk@post.tau.ac.il

Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: Alex 1 Guber, MD Meir Medical Center

Publications:
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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT02658045     History of Changes
Other Study ID Numbers: 0172-15MMC
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: November 2015
Keywords provided by Meir Medical Center:
oxygen saturation
monitoring
oximeter
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases