The Effect of Spontaneous Respiration on Pulse-oximetry Measurements

Not Applicable

• Conditions: Interstitial Lung Disease; COPD; Chronic Respiratory Disease

• Registration Number: NCT04139356
• Lead Sponsor: Universidad Autonoma de Nuevo Leon

Brief 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.

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 Timeline

• Study Start: 2019-09-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-23
• Last Update Submitted: 2019-10-23
• Study First Posted: 2019-10-25
• Last Update Posted: 2019-10-25
• Primary Completion: 2019-11-15
• Study Completion: 2019-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cardiac output (CO)	Lenght of experimental protocol: 6 minutes.	In a subset of 13 patients with the greater increase on O2Sat, CO will be measured during the same protocol
Vd/VT	Lenght of experimental protocol: 6 minutes.	In a subset of 13 patients with the greater increase on O2Sat, Vd/Vt will be measured during the same protocol
CT recruitment	Lenght of experimental protocol: 6 minutes.	In a subset of 13 patients with the greater increase on O2Sat, CT recruitment will be calculated using densitometry values during the same protocol

Trial Locations

Locations (1)

Facultad de Medicina y Hospital Universitario UANL; 🇲🇽 Monterrey, Nuevo Leon, Mexico