The Impact of High-Flow Nasal Cannula on Swallow Function

NCT03590457 | Completed Results FDA Device

• 1 other identifier: 18012503
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Swallowing Disorder; Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• Swallow Frequency Recorded by Surface Electromyography (sEMG)

  Number of swallows

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

Study Arms (1)

High-Flow/Swallow

OTHER

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

Device: Airvo 2; High-Flow nasal cannula system

Interventions

Airvo 2; High-Flow nasal cannula system DEVICE

Noninvasive device used to deliver humidified oxygen at high flow rates up to 60 liters per minute

High-Flow/Swallow

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• No cognitive impairments

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60187, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Respiration Disorders; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Brady Scott
• Organization: Rush University

jonathan_b_scott@rush.edu

3129426389

Study Officials

• Jonathan B Scott, PhD

  Rush University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director of Clinical Education

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 18, 2018
• Study Start: June 22, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 27, 2022
• Results First Posted: September 27, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)