Chronic Respiratory DiseaseNCT04139356
The Effect of Spontaneous Respiration on Pulse-oximetry Measurements
A study testing Deep breaths in people with Chronic Respiratory Disease and COPD, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Disease, COPD, Interstitial Lung Disease
- What is being tested?
- Deep breaths
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2019to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Facultad de Medicina y Hospital Universitario UANL
Monterrey, Nuevo León, 64630
Uriel Chavarria, MD, +528183482018, uriel_chavarria@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Respiratory Disease, COPD, Interstitial Lung Disease
- Being tested
- Deep breaths
- Keywords
- pulseoxymetry, capnography, Dead space, cardiac output, lung recruitment, deep breaths
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep breathsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with rest O2 desaturation | Experimental | Patient will undergo an experimental protocol consisting of 10 deep inspirations to measure and characterize changes on pulse-oxymetry values Receives: Procedure: Deep breaths |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in O2 saturation
A Saturation change greater than 4% will be considered significant
Measured: Lenght of experimental protocol: 6 minutes.
Secondary outcomes (3)
Vd/VT
In a subset of 13 patients with the greater increase on O2Sat, Vd/Vt will be measured during the same protocol
Measured: 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
Measured: 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
Measured: Lenght of experimental protocol: 6 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start1 Sep 2019
- Primary completion15 Nov 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical experimental trial of changes in pulse-oxymetry measurements with deep inspirations
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uriel Chavarria-Martinez, Universidad Autonoma de Nuevo Leon
- Investigators
- Uriel Chavarria, MD, Principal investigator, Facultad de Medicina y Hospital Universitario UANL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139356
- Sponsor's protocol ID
- UAutonomaNL
- Status last verified
- Oct 2019
- First submitted
- 23 Oct 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Spontaneous Respiration on Pulse-oximetry Measurements and Analysis of Variability Mechanisms
- ClinicalTrials.gov ID
- NCT04139356
- Acronym / sponsor ID
- UAutonomaNL
- Conditions
- Chronic Respiratory Disease, COPD, Interstitial Lung Disease
- Keywords
- pulseoxymetry, capnography, Dead space, cardiac output, lung recruitment, deep breaths
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 15 Nov 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical experimental trial of changes in pulse-oxymetry measurements with deep inspirations
| Arm | Type | Receives |
|---|---|---|
| Patients with rest O2 desaturation | Experimental | Procedure: Deep breathsPatient will undergo an experimental protocol consisting of 10 deep inspirations to measure and characterize changes on pulse-oxymetry values |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep breathsPatients 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. | Procedure or surgery | Patients with rest O2 desaturation |
Primary outcome
Change in O2 saturation
Time frame: Lenght of experimental protocol: 6 minutes.
A Saturation change greater than 4% will be considered significant
3 secondary outcomes
Vd/VT
Time frame: Lenght of experimental protocol: 6 minutes.
Cardiac output (CO)
Time frame: Lenght of experimental protocol: 6 minutes.
CT recruitment
Time frame: Lenght of experimental protocol: 6 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uriel Chavarria, MD principal investigator
Facultad de Medicina y Hospital Universitario UANL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep breaths in people with Chronic Respiratory Disease and COPD, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uriel Chavarria, MD (+528183482018, uriel_chavarria@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in O2 saturation (time frame: Lenght of experimental protocol: 6 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019.