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The Effect of Spontaneous Respiration on Pulse-oximetry Measurements

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04139356
Enrollment
45
Registered
2019-10-25
Start date
2019-09-01
Completion date
2019-12-15
Last updated
2019-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Respiratory Disease, COPD, Interstitial Lung Disease

Keywords

pulseoxymetry, capnography, Dead space, cardiac output, lung recruitment, deep breaths

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.

Interventions

PROCEDUREDeep 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.

Sponsors

Universidad Autonoma de Nuevo Leon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Clinical experimental trial of changes in pulse-oxymetry measurements with deep inspirations

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in O2 saturationLenght of experimental protocol: 6 minutes.A Saturation change greater than 4% will be considered significant

Secondary

MeasureTime frameDescription
CT recruitmentLenght 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
Vd/VTLenght 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
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

Countries

Mexico

Contacts

Primary ContactUriel Chavarria, MD
uriel_chavarria@hotmail.com+528183482018

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026