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

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT01873092
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Status Verified: 2013-06
• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-05
• Last Update Submitted: 2013-06-05
• Study First Posted: 2013-06-07
• Last Update Posted: 2013-06-07
• Primary Completion: 2014-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ambulatory oximetry/activity profile	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.

Trial Locations

Locations (1)

VA, New York Harbor Healthcare Service; 🇺🇸 Brooklyn, New York, United States