Validation and Characterization of Signal Decrease on an Oximeter in COPD (They Have Chronic Obstructive Pulmonary Disease) Patients During Deep Inhalation ( (OXYMETRE)

May 27, 2019 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Validation and Characterization of Signal Decrease on an Oximeter in Chronic Obstructive Pulmonary Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy Volunteers
oxymetry and finger pressure in Healthy subjects
Other: Measurements of oxygen saturation and finger pressure during deep inspiration
Measurements during deep inspiration of oxygen saturation with pulse oximeter and finger pressure with pressure cuff
Experimental: COPD patients
oxymetry and finger pressure in COPD patients
Other: Measurements of oxygen saturation and finger pressure during deep inspiration
Measurements during deep inspiration of oxygen saturation with pulse oximeter and finger pressure with pressure cuff

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
drop in oxygen saturation during deep inspiration in COPD
Time Frame: from the intervention to 3 minutes after the start of the intervention
saturation is measured in percentage (SPO2)
from the intervention to 3 minutes after the start of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Giuseppe Liistro, PhD, MD, Cliniques Universitaires Saint-luc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2019

Primary Completion (Actual)

May 10, 2019

Study Completion (Actual)

May 10, 2019

Study Registration Dates

First Submitted

May 27, 2019

First Submitted That Met QC Criteria

May 27, 2019

First Posted (Actual)

May 29, 2019

Study Record Updates

Last Update Posted (Actual)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 27, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/25AVR/185

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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