Healthy VolunteersNCT05550935
Physiological Effects of High-flow Nasal Cannula During Exercise
A study testing High-flow Nasal Cannula in people with Healthy Volunteers, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The high-flow nasal cannula (HFNC) has increased its evidence in patients during pulmonary rehabilitation. These studies hypothesize that the physiological effects of HFNC (positive expiratory pressure, anatomical dead space lavage, thermo-humidification) lead to an increase in exercise time. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- High-flow Nasal Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteChile
- Study dates
- 25 Jul 2022to 29 Jan 2023
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults volunteers
- Physically inactive (according to World Health Organization criteria).
Who cannot join
- Refusal to participate
- Smokers
- History of acute cardiorespiratory or musculoskeletal disease during the last year (including COVID-19 when hospitalization or supplemental oxygen was required without any other disease)
- Any neuromuscular or cardiovascular or condition that limits test performance.
- Contraindication for esophageal catheter installation (recent epistaxis, severe coagulopathy, among other).
Trial locations and contacts
1 site in 1 country.
Chile1 site
Laboratorio de Fisiología del Ejercicio, Departamento Ciencias de la Salud, Facultad de Medicina, Pontificia Universidad Católica de Chile.
Santiago, Provincia, 7820436
About this study
Official title: Effects of High-flow Nasal Cannula on the Distribution of Pulmonary Ventilation and Respiratory Effort in Healthy Subjects During Exercise.
The high-flow nasal cannula (HFNC) has increased its evidence in patients during pulmonary rehabilitation. These studies hypothesize that the physiological effects of HFNC (positive expiratory pressure, anatomical dead space lavage, thermo-humidification) lead to an increase in exercise time. This is believed to be due to improvements that the device can generate in the respiratory system and muscles. However, the physiological effects of HFNC on respiratory effort and distribution of pulmonary ventilation during exercise are unknown. The aim of this study is to determine the acute effect of high flow nasal cannula on the distribution of pulmonary ventilation and respiratory effort during physical exercise in healthy subjects.
Read the detailed description
A randomized, cross-over clinical trial in which either HFNC or Sham may be used as an adjunct on a cycle ergometer in random order will be performed to compare the respiratory effort and distribution of pulmonary ventilation continuously. Measurements will be taken in a warm-up, exercise, and recovery phase for both groups.
- Conditions
- Healthy Volunteers
- Being tested
- High-flow Nasal Cannula
- Keywords
- High-Flow Nasal Cannula, Electrical Impedance Tomography, Respiratory Physiology, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow Nasal CannulaDevice
Also called HFNC
HFNC is a device that, in this study, will give the maximum flow (60 L/min), with minimum adjusted temperature (31°C) and FiO2 of 21% or room air.
| Study group | Role | What they receive |
|---|---|---|
| HFNC Group | Experimental | Healthy subject will perform one Constant Work-Rate Exercise Test at respiratory compensation point as determined by a cardiopulmonary exercise test with High Flow Nasal at 60L/min (without additional oxygen) Receives: Device: High-flow Nasal Cannula |
| Control Group | Sham comparator | Healthy subject will perform one Constant Work-Rate Exercise Test at respiratory compensation point as determined by a cardiopulmonary exercise test with High Flow Nasal at 2L/min (without additional oxygen) Receives: Device: High-flow Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory effort
The average esophageal pressure swings during inspiration (ΔPes) defined as the absolute differences between end-expiratory and end-inspiratory Pes over a period of 60 seconds. Measurements will be during warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Standard deviation of regional ventilation delay index (RVDsd)
as a measure of temporal distribution of ventilation: defined as the average of 10 breaths representative of the 60 seconds evaluated in each period. Measurements will be during warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Secondary outcomes (15)
Work of breathing
The average pressure time product over a minute (PTPmin), defined as the sum of the areas subtended by the Pes waveform during inspiration over 60 seconds. Measurements will be during warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Work of breathing per single breath
The average per-breath pressure time product (PTP), defined as the area subtended by the Pes waveform during inspiration in a series of representative and valid breaths divided by the number of breaths (at least five to ten) over 60 seconds. Measurements will be during warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Respiratory drive
The average of negative pressure measured 500 ms after the initiation of an inspiratory effort defined as the defection in Pes during the first 0.5 s during inspiration in a series of representative and valid breaths divided by the number of breaths (at least five to ten) over 60 seconds. Also, The average slope of the inspiratory negative Pes swings from the start of inspiration to the minimum pressure (ΔPes/Δt) in a series of representative and valid breaths divided by the number of breaths (at least five to ten) over 60 seconds.
Measurements will be during warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Tidal Variation (TV) as a measure of variation during tidal breathing
defined as the average of differences between end-expiratory lung impedance (EELI) and end-inspiratory lung impedance (EILV) in 60 seconds for each period evaluated warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
End-Expiratory Lung Impedance (EELI), as a measure lung aeration
average of end-expiratory lung impedance respectively, in 60 seconds for each period evaluated warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Normalized Tidal Variation (TV) as a measure of variation during tidal breathing
defined as the average of differences between end-expiratory lung impedance (EELI) and end-inspiratory lung impedance (EILV) divided by the number of breaths evaluated in each period (60 seconds).Measurements will be during warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Normalized End-Expiratory Lung Impedance (EELI)
as a measure lung aeration: defined as the average of end-expiratory lung impedance divided by the number of breaths evaluated in each period (60 seconds). Measurements will be during warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Global inhomogeneity index (GI) as a measure of spatial distribution of tidal ventilation
defined as the value of the tidal image in 60 seconds for each period evaluated. Measurements will be during warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Center of ventilation (COV), dorsal fraction of ventilation (TVd) and anterior-to-posterior ventilation ratio (Impedance ratio), most dorsal region of interest (ROI4) (TVroi4), as a measure of ventilation distribution influenced by gravity.
defined as the value of the tidal image in 60 seconds for each period evaluated. Measurements will be during warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Dyspnea and leg fatigue
: using Modified Borg Scale (0 - 10 points) for each period evaluated warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Heart rate
using a pulse oximetry for each period evaluated warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Pulse oxygen saturation
using a pulse oximetry for each period evaluated warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Respiratory rate
using a electrical impedance tomography for each period evaluated warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Blood pressure
Using a sphygmomanometer and stethoscope will be evaluated at the beginning (basal), end of the exercise, and during the recovery phase by the same operator.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately seven days, for a total time frame of 3 weeks maximum per participant. Data will be collected during the basal and recovery phase
Comfort scale associated with dispositive
using visual analog likert scale (0-5: 0: "nothing comfortable" to 5: "totally comfortable") evaluated before and at the end of the exercise.
Measured: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during the basal and end-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start25 Jul 2022
- Primary completion13 Sep 2022
- Study completion29 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants receive one of two alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricio Garcia, PhD(C), Principal investigator, Departamento Ciencias de la Salud, Facultad de Medicina, Pontificia Universidad Católica de Chile.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550935
- Sponsor's protocol ID
- 220510003
- Status last verified
- Sep 2022
- First submitted
- 16 Sep 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will evaluate IPD sharing since it is not intended a priori to perform an inferential analysis with statistics to evaluate the results before completing the study. In addition, it is a physiological study requiring only three days per subject (Approximately three weeks total) and with a low sample size.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-flow Nasal Cannula on the Distribution of Pulmonary Ventilation and Respiratory Effort in Healthy Subjects During Exercise.
- ClinicalTrials.gov ID
- NCT05550935
- Acronym / sponsor ID
- 220510003
- Conditions
- Healthy Volunteers
- Keywords
- High-Flow Nasal Cannula, Electrical Impedance Tomography, Respiratory Physiology, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 29 Jan 2023 (actual)
- First posted
- 22 Sep 2022 (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.
The high-flow nasal cannula (HFNC) has increased its evidence in patients during pulmonary rehabilitation. These studies hypothesize that the physiological effects of HFNC (positive expiratory pressure, anatomical dead space lavage, thermo-humidification) lead to an increase in exercise time. This is believed to be due to improvements that the device can generate in the respiratory system and muscles. However, the physiological effects of HFNC on respiratory effort and distribution of pulmonary ventilation during exercise are unknown. The aim of this study is to determine the acute effect of high flow nasal cannula on the distribution of pulmonary ventilation and respiratory effort during physical exercise in healthy subjects.
Detailed description
A randomized, cross-over clinical trial in which either HFNC or Sham may be used as an adjunct on a cycle ergometer in random order will be performed to compare the respiratory effort and distribution of pulmonary ventilation continuously. Measurements will be taken in a warm-up, exercise, and recovery phase for both groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants receive one of two alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study
| Arm | Type | Receives |
|---|---|---|
| HFNC Group | Experimental | Device: High-flow Nasal CannulaHealthy subject will perform one Constant Work-Rate Exercise Test at respiratory compensation point as determined by a cardiopulmonary exercise test with High Flow Nasal at 60L/min (without additional oxygen) |
| Control Group | Sham comparator | Device: High-flow Nasal CannulaHealthy subject will perform one Constant Work-Rate Exercise Test at respiratory compensation point as determined by a cardiopulmonary exercise test with High Flow Nasal at 2L/min (without additional oxygen) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults volunteers
- Physically inactive (according to World Health Organization criteria).
Key exclusion criteria (5 listed)
- Refusal to participate
- Smokers
- History of acute cardiorespiratory or musculoskeletal disease during the last year (including COVID-19 when hospitalization or supplemental oxygen was required without any other disease)
- Any neuromuscular or cardiovascular or condition that limits test performance.
- Contraindication for esophageal catheter installation (recent epistaxis, severe coagulopathy, among other).
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 |
|---|---|---|
| High-flow Nasal CannulaAlso: HFNCHFNC is a device that, in this study, will give the maximum flow (60 L/min), with minimum adjusted temperature (31°C) and FiO2 of 21% or room air. | Device | Control Group, HFNC Group |
Primary outcome
Inspiratory effort
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
The average esophageal pressure swings during inspiration (ΔPes) defined as the absolute differences between end-expiratory and end-inspiratory Pes over a period of 60 seconds. Measurements will be during warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
Standard deviation of regional ventilation delay index (RVDsd)
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
as a measure of temporal distribution of ventilation: defined as the average of 10 breaths representative of the 60 seconds evaluated in each period. Measurements will be during warm-up (one minute of five minutes), exercise (minutes: 0-1'; 3-4'; 5-6'), and the recovery phase (minutes: 0-1'; 1-2'; 3-4'; 5-6';7-8';9-10') for both groups.
15 secondary outcomes
Work of breathing
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Work of breathing per single breath
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Respiratory drive
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Tidal Variation (TV) as a measure of variation during tidal breathing
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
End-Expiratory Lung Impedance (EELI), as a measure lung aeration
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Normalized Tidal Variation (TV) as a measure of variation during tidal breathing
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Normalized End-Expiratory Lung Impedance (EELI)
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Global inhomogeneity index (GI) as a measure of spatial distribution of tidal ventilation
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Center of ventilation (COV), dorsal fraction of ventilation (TVd) and anterior-to-posterior ventilation ratio (Impedance ratio), most dorsal region of interest (ROI4) (TVroi4), as a measure of ventilation distribution influenced by gravity.
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Dyspnea and leg fatigue
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Heart rate
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Pulse oxygen saturation
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Respiratory rate
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery
Blood pressure
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately seven days, for a total time frame of 3 weeks maximum per participant. Data will be collected during the basal and recovery phase
Comfort scale associated with dispositive
Time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during the basal and end-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No. The investigators will evaluate IPD sharing since it is not intended a priori to perform an inferential analysis with statistics to evaluate the results before completing the study. In addition, it is a physiological study requiring only three days per subject (Approximately three weeks total) and with a low sample size.
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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.
Patricio Garcia, PhD(C) principal investigator
Departamento Ciencias de la Salud, Facultad de Medicina, Pontificia Universidad Católica de Chile.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow Nasal Cannula in people with Healthy Volunteers, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 7 Dec 2023. 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 Chile. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory effort (time frame: at 3 weeks. Outcome will be measured during the CWRET and will be carried out on different days, separate from approximately 7 days, for a total time frame of 3 weeks maximum per participant. Data will be collected during warm-up, exercise, and recovery). The study lists 2 primary outcomes in all. 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 7 Dec 2023.