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AMBULATORY OXIMETRY MONITORING (AOM): a New Approach to Quantify Oxygen Desaturation in Ambulatory COPD Patients

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ClinicalTrials.gov Identifier: NCT01873092
Recruitment Status : Unknown
Verified June 2013 by Miriam D Cohen, VA New York Harbor Healthcare System.
Recruitment status was:  Active, not recruiting
First Posted : June 7, 2013
Last Update Posted : June 7, 2013
Sponsor:
Information provided by (Responsible Party):
Miriam D Cohen, VA New York Harbor Healthcare System

Brief Summary:
Chronic obstructive lung disease (COPD) is characterized by airflow obstruction that is progressive over many years and is largely irreversible. Advanced COPD is associated with arterial oxygen desaturation leading to a series of complications and, ultimately, decreased survival. Long-term oxygen therapy can improve clinical outcomes in these patients, but the exact target of oxygen saturation that actually translates into improvements is not known. The basis for the work in this proposal is to focus a new approach to measure oxygen desaturation linked to daily activity. Accelerometers are used to measure daily activity and then synchronized with ambulatory oximetry to establish an activity/oxygen-saturation profile for individual patients. The three main objectives of this study are 1) determine the feasibility of AOM as a measurement of the temporal profile of oxygen saturation in patients with chronic lung disease; 2) determine if serial AOM-derived data is reliable and reproducible; and 3) determine thresholds of oxygen desaturation that are associated with different activity profiles

Condition or disease
Pulmonary Disease, Chronic Obstructive

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AMBULATORY OXIMETRY MONITORING (AOM): a New Approach to Quantify Oxygen Desaturation in Ambulatory COPD Patients
Study Start Date : May 2003
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with COPD
Patients who meet criteria for chronic obstructive pulmonary disease



Primary Outcome Measures :
  1. Ambulatory oximetry/activity profile [ Time Frame: Data is collected over 30-34 consecutive hours ]
    Oxygen saturation is measured with a pulse oximeter that has the capacity to collect data over 30- 34 hours; physical activity is measured with two pizo-electric accelerometers. Oximetry and activity data are synchronized to define a profile of oxygen saturation that is linked to usual daily activity.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Veteran patients with chronic obstructive pulmonary disease
Criteria

Inclusion Criteria:

  1. Veteran patients with a diagnosis of COPD or other chronic lung disease
  2. able to read and understand English
  3. > 45 years old
  4. ambulatory and able to perform functional testing

Exclusion Criteria:

  1. unable or unwilling to give informed consent
  2. daily use of a motorized cart
  3. impairment of cognition or communication
  4. history of drug or alcohol treatment within the past 6 months
  5. poor peripheral blood flow to the finger rendering oxygen saturation by pulse oximetry unreliable
  6. Recent acute medical events (chest pain, discomfort, etc) that would suggest a contraindication to participate at the scheduled time

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): NCT01873092


Locations
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United States, New York
VA, New York Harbor Healthcare Service
Brooklyn, New York, United States, 11209
Sponsors and Collaborators
VA New York Harbor Healthcare System
Investigators
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Principal Investigator: Miriam Cohen VA New York Harbor Healthcare System

Publications of Results:
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Responsible Party: Miriam D Cohen, Nurse Practitioner, VA New York Harbor Healthcare System
ClinicalTrials.gov Identifier: NCT01873092     History of Changes
Other Study ID Numbers: 00493
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2013

Keywords provided by Miriam D Cohen, VA New York Harbor Healthcare System:
Oximetry
Physical Activity

Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive