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

NCT ID: NCT01873092

Last Updated: 2013-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-05-31

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with COPD

Patients who meet criteria for chronic obstructive pulmonary disease

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA New York Harbor Healthcare System

FED

Sponsor Role lead

Responsible Party

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Miriam D Cohen

Nurse Practitioner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miriam Cohen

Role: PRINCIPAL_INVESTIGATOR

VA New York Harbor Healthcare System

Locations

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VA, New York Harbor Healthcare Service

Brooklyn, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20216326 (View on PubMed)

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.

Reference Type RESULT
PMID: 22409288 (View on PubMed)

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.

Reference Type RESULT
PMID: 21701832 (View on PubMed)

Other Identifiers

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00493

Identifier Type: -

Identifier Source: org_study_id

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