Clinical trial NCT05550935: Physiological Effects of High-flow Nasal Cannula During Exercise
Official title: Effects of High-flow Nasal Cannula on the Distribution of Pulmonary Ventilation and Respiratory Effort in Healthy Subjects During Exercise.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: High-Flow Nasal Cannula
Electrical Impedance Tomography
Respiratory Physiology
Exercise
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Healthy adults volunteers
* Physically inactive (according to World Health Organization criteria).

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Inspiratory effort
timeFrame: 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
measure: Standard deviation of regional ventilation delay index (RVDsd)
timeFrame: 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:
measure: Work of breathing
timeFrame: 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
measure: Work of breathing per single breath
timeFrame: 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
measure: Respiratory drive
timeFrame: 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
measure: Tidal Variation (TV) as a measure of variation during tidal breathing
timeFrame: 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
measure: End-Expiratory Lung Impedance (EELI), as a measure lung aeration
timeFrame: 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
measure: Normalized Tidal Variation (TV) as a measure of variation during tidal breathing
timeFrame: 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
measure: Normalized End-Expiratory Lung Impedance (EELI)
timeFrame: 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
measure: Global inhomogeneity index (GI) as a measure of spatial distribution of tidal ventilation
timeFrame: 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
measure: 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.
timeFrame: 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
measure: Dyspnea and leg fatigue
timeFrame: 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
measure: Heart rate
timeFrame: 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
measure: Pulse oxygen saturation
timeFrame: 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
measure: Respiratory rate
timeFrame: 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
measure: Blood pressure
timeFrame: 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
measure: Comfort scale associated with dispositive
timeFrame: 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
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Laboratorio de Fisiología del Ejercicio, Departamento Ciencias de la Salud, Facultad de Medicina, Pontificia Universidad Católica de Chile.
state: Provincia
Study officials:
affiliation: Departamento Ciencias de la Salud, Facultad de Medicina, Pontificia Universidad Católica de Chile.
name: Patricio Garcia, PhD(C)
role: PRINCIPAL_INVESTIGATOR
References: