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Physiological Effects of High-flow Nasal Cannula During Exercise

NCT ID: NCT05550935

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-25

Study Completion Date

2023-01-29

Brief Summary

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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

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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

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Healthy Volunteers

Keywords

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High-Flow Nasal Cannula Electrical Impedance Tomography Respiratory Physiology Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

An attempt will be made to keep the research team performing the measurements masked to the healthy subject assignment until the first day of the Constant Work-Rate Exercise Test (first random order).

An attempt will be made to keep the participant masked by simulation with HFNC at 2 L/min and separation of one week between the two exercise tests to forget the effect of the high flow and sound of the device.

Study Groups

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HFNC Group

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)

Group Type EXPERIMENTAL

High-flow Nasal Cannula

Intervention Type DEVICE

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.

Control Group

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)

Group Type SHAM_COMPARATOR

High-flow Nasal Cannula

Intervention Type DEVICE

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.

Interventions

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High-flow Nasal Cannula

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.

Intervention Type DEVICE

Other Intervention Names

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HFNC

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricio Garcia, PhD(C)

Role: PRINCIPAL_INVESTIGATOR

Departamento Ciencias de la Salud, Facultad de Medicina, Pontificia Universidad Católica de Chile.

Locations

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Laboratorio de Fisiología del Ejercicio, Departamento Ciencias de la Salud, Facultad de Medicina, Pontificia Universidad Católica de Chile.

Santiago, Provincia, Chile

Site Status

Countries

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Chile

Other Identifiers

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220510003

Identifier Type: -

Identifier Source: org_study_id