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The Effect of Spontaneous Respiration on Pulse-oximetry Measurements

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04139356
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Universidad Autonoma de Nuevo Leon
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Uriel Chavarria, MD
Principal Investigator Affiliation	Facultad de Medicina y Hospital Universitario UANL
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Mexico
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Respiratory Disease, COPD, Interstitial Lung Disease

Additional Details

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.

Arms & Interventions

Arms

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

Interventions

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.

Contact a Trial Team

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