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

NCT01873092 | Unknown

• 1 other identifier: 00493
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Oximetry; Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with COPD

Patients who meet criteria for chronic obstructive pulmonary disease

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veteran patients with chronic obstructive pulmonary disease

You may qualify if:

• Veteran patients with a diagnosis of COPD or other chronic lung disease
• able to read and understand English
• \> 45 years old
• ambulatory and able to perform functional testing

You may not qualify if:

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

Sponsors & Collaborators

• VA New York Harbor Healthcare System: lead

Study Sites (1)

VA, New York Harbor Healthcare Service

Brooklyn, New York, 11209, United States

Location

Related Publications (3)

• 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.

  PMID: 20216326 RESULT

• 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.

  PMID: 22409288 RESULT

• 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.

  PMID: 21701832 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Miriam Cohen

  VA New York Harbor Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Practitioner

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 7, 2013
• Study Start: May 1, 2003
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: June 7, 2013

Record last verified: 2013-06

Locations

US (1)