Effects of High-flow Nasal Cannula on the Distribution of Pulmonary Ventilation and Respiratory Effort in Healthy Subjects During Exercise.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Standard deviation of regional ventilation delay index (RVDsd)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults volunteers
- •Physically inactive (according to World Health Organization criteria).
排除标准
- •Refusal to participate
- •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).
研究组 & 干预措施
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)
干预措施: High-flow Nasal Cannula (Device)
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)
干预措施: High-flow Nasal Cannula (Device)
结局指标
主要结局
Standard deviation of regional ventilation delay index (RVDsd)
时间窗: 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.
Inspiratory effort
时间窗: 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.
次要结局
- Heart rate(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(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.(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)
- Comfort scale associated with dispositive(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)
- Pulse oxygen saturation(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(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)
- 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)
- Normalized 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)
- Dyspnea and leg fatigue(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)
- Normalized End-Expiratory Lung Impedance (EELI)(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(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(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)