The Effect of Spontaneous Respiration on Pulse-oximetry Measurements

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

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.

Study Overview

• Status: Unknown
• Conditions: Interstitial Lung Disease; COPD; Chronic Respiratory Disease
• Intervention / Treatment: Procedure: Deep breaths

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Uriel Chavarria, MD; Phone Number: +528183482018; Email: uriel_chavarria@hotmail.com

Study Locations

• Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64630
      • Recruiting
      • Facultad de Medicina y Hospital Universitario UANL
      • Contact: Uriel Chavarria, MD; Phone Number: +528183482018; Email: uriel_chavarria@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with rest O2 desaturation; Patient will undergo an experimental protocol consisting of 10 deep inspirations to measure and characterize changes on pulse-oxymetry values	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in O2 saturation	A Saturation change greater than 4% will be considered significant	Lenght of experimental protocol: 6 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Nuevo Leon
• Investigators: Principal Investigator: Uriel Chavarria, MD, Facultad de Medicina y Hospital Universitario UANL

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): November 15, 2019
• Study Completion (Anticipated): December 15, 2019

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): October 25, 2019
• Last Update Submitted That Met QC Criteria: October 23, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: capnography; cardiac output; lung recruitment; Dead space; pulseoxymetry; deep breaths
• Additional Relevant MeSH Terms: Lung Diseases; Lung Diseases, Interstitial; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: UAutonomaNL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No