Validation and Characterization of Signal Decrease on an Oximeter in COPD (They Have Chronic Obstructive Pulmonary Disease) Patients During Deep Inhalation ( (OXYMETRE)
Primary Purpose
Pulmonary Disease, Copd
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Measurements of oxygen saturation and finger pressure during deep inspiration
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Disease focused on measuring COPD
Eligibility Criteria
healthy arm
Inclusion Criteria:
- Healthy adults volunteers are recruited from students with normal lung function.
Exclusion Criteria:
- abnormal lung function
COPD Arm
Inclusion Criteria:
- Adults with Chronic Obstructive pulmonary disease
Exclusion Criteria:
- cardiovascular disease
The subjects selected are selected on a voluntary basis among the patients coming to the pulmonary consultation. They have Chronic Obstructive Pulmonary Disease.
Sites / Locations
- Cliniques universitaires Saint-Luc
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Healthy Volunteers
COPD patients
Arm Description
oxymetry and finger pressure in Healthy subjects
oxymetry and finger pressure in COPD patients
Outcomes
Primary Outcome Measures
drop in oxygen saturation during deep inspiration in COPD
saturation is measured in percentage (SPO2)
Secondary Outcome Measures
Full Information
NCT ID
NCT03966196
First Posted
May 27, 2019
Last Updated
May 27, 2019
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT03966196
Brief Title
Validation and Characterization of Signal Decrease on an Oximeter in COPD (They Have Chronic Obstructive Pulmonary Disease) Patients During Deep Inhalation (
Acronym
OXYMETRE
Official Title
Validation and Characterization of Signal Decrease on an Oximeter in Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
May 10, 2019 (Actual)
Study Completion Date
May 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective is to verify that there is a decrease in the pulsed oxygen saturation with the digital sensor. That is, the drop in oxygen saturation in COPD patients during inhalation is real and not due to an artifact of the measuring tool, because oximeters need a quality pulsatile signal to properly measure oxygen saturation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Copd
Keywords
COPD
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
half healthy subject, half COPD patients
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteers
Arm Type
Other
Arm Description
oxymetry and finger pressure in Healthy subjects
Arm Title
COPD patients
Arm Type
Experimental
Arm Description
oxymetry and finger pressure in COPD patients
Intervention Type
Other
Intervention Name(s)
Measurements of oxygen saturation and finger pressure during deep inspiration
Intervention Description
Measurements during deep inspiration of oxygen saturation with pulse oximeter and finger pressure with pressure cuff
Primary Outcome Measure Information:
Title
drop in oxygen saturation during deep inspiration in COPD
Description
saturation is measured in percentage (SPO2)
Time Frame
from the intervention to 3 minutes after the start of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
healthy arm
Inclusion Criteria:
Healthy adults volunteers are recruited from students with normal lung function.
Exclusion Criteria:
abnormal lung function
COPD Arm
Inclusion Criteria:
Adults with Chronic Obstructive pulmonary disease
Exclusion Criteria:
cardiovascular disease
The subjects selected are selected on a voluntary basis among the patients coming to the pulmonary consultation. They have Chronic Obstructive Pulmonary Disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Liistro, PhD, MD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Validation and Characterization of Signal Decrease on an Oximeter in COPD (They Have Chronic Obstructive Pulmonary Disease) Patients During Deep Inhalation (
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