The Effect of Spontaneous Respiration on Pulse-oximetry Measurements

COPD Clinical Trial

Official title:

The Effect of Spontaneous Respiration on Pulse-oximetry Measurements and Analysis of Variability Mechanisms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04139356
• Other study ID #: UAutonomaNL
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: October 2019
• Source: Universidad Autonoma de Nuevo Leon
• Contact: Uriel Chavarria, MD
• Phone: +528183482018
• Email: uriel_chavarria[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study designed to measure, characterize and describe changes on pulse-oxymetry values produced as a result of deep breaths in patients with stable chronic hypoxemic respiratory failure.

Description:

There is no standard way of measuring rest pulse-oxymetry in terms of depth of respiration. Rest pulse-oxymetry values are used in the clinical setting to make therapeutic decisions regarding the need of supplemental oxygen. The primary goal of this study is to measure the change of pulse-oxymetry values during an experimental protocol of 10 deep breaths during one minute in patients with chronic hypoxemia. 45 patients will be studied in this first phase. In a second phase, secondary goals will be to measure Vd/Vt vent, noninvasive cardiac output and CT densitometry during the same deep breaths protocol in a subset of 13 patients with the grater increase observed in the first phase of study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with chronic lung disease causing rest hypoxemia, with rest SpO2 values equal or lower than 94% on room air

• Ambulatory patients capable of performing 6 min walking test

• Patients older than 18 years old.

Exclusion Criteria:

• Patients with significant collagen disease causing Raynaud phenomenon.

• Patients with hypothermia lower than 35 degrees Celsius

• Patients with rest SpO2 values equal or lower than 80% on room air

• Patients unable to perform PFTs

• Patients unable to complete 6 min walking test without supp O2.

• Patients unable to perform experimental deep breaths on CT scan

Related Conditions & MeSH terms

• Chronic Respiratory Disease
• COPD
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Procedure:
• Deep breaths
Patients will undergo a 6 minutes protocol. Baseline: 1 minute normal breaths. Intervention: 1 minute with 10 deep breaths, 1 each 6 secs. Pulse-oxymetry will be continuously recorded.

Locations

Country	Name	City	State
Mexico	Facultad de Medicina y Hospital Universitario UANL	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Nuevo Leon

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in O2 saturation	A Saturation change greater than 4% will be considered significant	Lenght of experimental protocol: 6 minutes.
Secondary	Vd/VT	In a subset of 13 patients with the greater increase on O2Sat, Vd/Vt will be measured during the same protocol	Lenght of experimental protocol: 6 minutes.
Secondary	Cardiac output (CO)	In a subset of 13 patients with the greater increase on O2Sat, CO will be measured during the same protocol	Lenght of experimental protocol: 6 minutes.
Secondary	CT recruitment	In a subset of 13 patients with the greater increase on O2Sat, CT recruitment will be calculated using densitometry values during the same protocol	Lenght of experimental protocol: 6 minutes.