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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

Tracking Information
First Submitted Date June 5, 2013
First Posted Date June 7, 2013
Last Update Posted Date June 7, 2013
Study Start Date May 2003
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2013)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title AMBULATORY OXIMETRY MONITORING (AOM): a New Approach to Quantify Oxygen Desaturation in Ambulatory COPD Patients
Official Title AMBULATORY OXIMETRY MONITORING (AOM): a New Approach to Quantify Oxygen Desaturation in Ambulatory COPD Patients
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Veteran patients with chronic obstructive pulmonary disease
Condition Pulmonary Disease, Chronic Obstructive
Intervention Not Provided
Study Groups/Cohorts Patients with COPD
Patients who meet criteria for chronic obstructive pulmonary disease
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 5, 2013)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2016
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01873092
Other Study ID Numbers 00493
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Miriam D Cohen, VA New York Harbor Healthcare System
Study Sponsor VA New York Harbor Healthcare System
Collaborators Not Provided
Investigators
Principal Investigator: Miriam Cohen VA New York Harbor Healthcare System
PRS Account VA New York Harbor Healthcare System
Verification Date June 2013