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

NCT03966196 | Completed

• 1 other identifier: 2018/25AVR/185
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Disease; Copd

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• drop in oxygen saturation during deep inspiration in COPD

  saturation is measured in percentage (SPO2)

  from the intervention to 3 minutes after the start of the intervention

Study Arms (2)

Healthy Volunteers

OTHER

oxymetry and finger pressure in Healthy subjects

Other: Measurements of oxygen saturation and finger pressure during deep inspiration

COPD patients

EXPERIMENTAL

oxymetry and finger pressure in COPD patients

Other: Measurements of oxygen saturation and finger pressure during deep inspiration

Interventions

Measurements of oxygen saturation and finger pressure during deep inspiration OTHER

Measurements during deep inspiration of oxygen saturation with pulse oximeter and finger pressure with pressure cuff

COPD patients; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults volunteers are recruited from students with normal lung function.

You may not qualify if:

• abnormal lung function
• COPD Arm
• Adults with Chronic Obstructive pulmonary disease
• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Giuseppe Liistro, PhD, MD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: half healthy subject, half COPD patients

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 29, 2019
• Study Start: February 11, 2019
• Primary Completion: May 10, 2019
• Study Completion: May 10, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)