跳至主要内容
临床试验/NCT03590457
NCT03590457已完成不适用

The Impact of High-Flow Nasal Cannula on Swallow Function

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年6月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Swallow Frequency Recorded by Surface Electromyography (sEMG)

研究概览

简要总结

Background: High-flow nasal cannula (HFNC) is a non-invasive heated and humidified oxygen delivery device that is capable of delivering high-flow rates. It is a relatively new modality that has been introduced as an alternative to conventional oxygen therapy. The clinical value of the use of HFNC is not limited to its ventilation and oxygenation effects, it enables the patient to talk and is purported to permit oral feeding during oxygen therapy despite the limited evidence regarding its impact on swallow function. This study will determine the impact of different flow rates of a high-flow nasal cannula on spontaneous swallowing frequency at rest and swallowing effort and timing while swallowing. Methods: This is a prospective study designed to measure swallowing frequency and swallowing effort in fifty healthy adult volunteers. Participants will receive three levels of HFNC flow rates (30, 45, and 60 L/min) through nasal prongs. The study participants will be asked to swallow measured amounts of water and applesauce and subjected to each flow rate for 15 minutes. Swallowing effort measurement through surface electromyography (sEMG) will be recorded at baseline and the three levels of HFNC flow rates interventions.

详细描述

High-flow nasal cannula (HFNC) is a non-invasive heated and humidified oxygen delivery device that is capable of delivering up to 60 L/min of flow. It is a relatively new modality that has been introduced as an alternative to conventional oxygen therapy in patients with chronic obstructive pulmonary disease (COPD) respiratory failure, obstructive sleep apnea (OSA)6, post-extubation, and status asthmaticus The humidified gas preserves mucociliary function that prevents secretion retention and enhances patient's comfort. This feature allows prolonged use of HFNC in clinical sittings of up to 30 days

In addition to its ability to provide adequate humidification levels, HFNC has various respiratory physiological effects. These physiological effects include: alveolar recruitment, dead space washout, and decreased airway resistance. The clinical value of the use of HFNC is not limited to its ventilation and oxygenation effects, it enables the patient to talk and is purported to permit oral feeding during oxygen therapy.

Currently, despite the fact that patients are often permitted to eat while receiving HFNC therapy, there is insufficient evidence regarding the impact of HFNC on swallow function. The uncertainty of the effect of this oxygen delivery device on swallow function arises not only from the limited number of studies, but also the contradictory results. For example, Sanuki et al. reported that increasing the flow rates of the HFNC resulted in enhanced swallow function by reducing reflex latency. Based on their findings, the researchers suggested that the use of HFNC should not affect the decision to start or resume feeding. Similarly, Lader et al. proposed that the use of high-flow nasal cannula should not delay oral alimentation. On the contrary, Ferrara et al. conducted a study in neonates and concluded that providing feeding while using Nasal Continuous Positive Airway Pressure (nCPAP) increased the risk of aspiration. These opposing outcomes support the need for further studies to obtain more definitive evidence.

Methods:

Spontaneous Swallowing Frequency:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •21 years of age or older
  • •No cognitive impairments

排除标准

  • •Less than 21 years old
  • •History of swallow dysphagia
  • •History of disease/condition that may cause dysphagia
  • •Use of medications that may alter swallow function
  • •Nasal obstruction
  • •Presence of tracheostomy tube

研究组 & 干预措施

High-Flow/Swallow

Other

All participants will be subjected to all three flows randomly. All participants will be asked swallow water and applesauce

干预措施: Airvo 2; High-Flow nasal cannula system (Device)

结局指标

主要结局

Swallow Frequency Recorded by Surface Electromyography (sEMG)

时间窗: each swallow frequency exam took 1 minute, exams were done for each flow rate which took up to 2 hours to complete

Number of swallows

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brady Scott

Associate Professor, Director of Clinical Education

Rush University Medical Center

研究点 (1)

Loading locations...

相似试验