Physiological Effects of High-flow Nasal Cannula During Exercise

NCT05550935 | Completed

• 1 other identifier: 220510003
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

High-Flow Nasal Cannula; Electrical Impedance Tomography; Respiratory Physiology; Exercise

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

  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

Study Arms (2)

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)

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)

Device: High-flow Nasal Cannula

Interventions

High-flow Nasal Cannula 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.

Also known as: HFNC

Control Group; HFNC Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

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

Santiago, Provincia, 7820436, Chile

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Patricio Garcia, PhD(C)

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 22, 2022
• Study Start: July 25, 2022
• Primary Completion: September 13, 2022
• Study Completion: January 29, 2023
• Last Updated: December 7, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)