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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01873092
• Other study ID #: 00493
• Status: Active, not recruiting
• Phase: N/A
• First received: June 5, 2013
• Last updated: June 5, 2013
• Start date: May 2003
• Est. completion date: December 2016

Study information

• Verified date: June 2013
• Source: VA New York Harbor Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United States	VA, New York Harbor Healthcare Service	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA New York Harbor Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cohen MD, Cutaia M, Brehm R, Brutus V, Pike VC, Lewendowski D. Detecting motor vehicle travel in accelerometer data. COPD. 2012 Apr;9(2):102-10. doi: 10.3109/15412555.2011.650238. Epub 2012 Mar 12. — View Citation

Cohen MD, Cutaia M. A novel approach to measuring activity in chronic obstructive pulmonary disease: using 2 activity monitors to classify daily activity. J Cardiopulm Rehabil Prev. 2010 May-Jun;30(3):186-94. doi: 10.1097/HCR.0b013e3181d0c191. — View Citation

Cutaia M, Brehm R, Cohen M. The relationship of the BODE index to oxygen saturation during daily activities in patients with chronic obstructive pulmonary disease. Lung. 2011 Aug;189(4):269-77. doi: 10.1007/s00408-011-9308-1. Epub 2011 Jun 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory oximetry/activity profile	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.	Data is collected over 30-34 consecutive hours	No