High-flow Nasal Cannula Oxygen Therapy for Ischemic Stroke Patients With Dysphagia and Obstructive Sleep Apnea

November 21, 2019 updated by: CHEN,CHUNG YAO, Chang Gung Memorial Hospital
High flow nasal cannula (HFNC) ventilation therapy was found to improve the severity of obstructive sleep apnea in non-stroke subjects. The investigators hypothesized that HFNC might be effective in stroke patients with dysphagia who needed nasogastric tube feeding and can not receive continuous positive airway pressure ventilation for obstructive sleep apnea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Keelung, Taiwan
        • Chang Gung Memorial Hospital, Keelung

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ischemic stroke patients with dysphagia and obstructive sleep apnea who need nasogastric tube feedings

Exclusion Criteria:

  • congestive heart failure, unconsciousness, chronic obstructive pulmonary disease, intracranial hemorrhage or malignancy, and unstable medical and neurological conditions
  • central sleep apnea

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HFNC
Device: high flow nasal cannula ventilation
High-flow nasal cannula (HFNC) ventilation therapy: supply heated & humidified air up to 60 L/min of flow; effects: positive end expiratory pressure effect, humidification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
apnea-hypopnea index
Time Frame: once at polysomnography study night when receive high flow nasal cannula titration study
respiratory inductance plethysmography sum (RIPsum) without calibration to score apnea and hypopnea events (American Academy of Sleep Medicine alternative criteria)
once at polysomnography study night when receive high flow nasal cannula titration study
oxyhemoglobin desaturation index
Time Frame: once at polysomnography study night when receive high flow nasal cannula titration study
number of times per hour of sleep that the blood's oxygen saturation level drops by ≥ 3% from baseline
once at polysomnography study night when receive high flow nasal cannula titration study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulse wave velocity
Time Frame: baseline and 1 week after high flow nasal cannula therapy
velocity (m/s) measured by SphygmoCor CPV system
baseline and 1 week after high flow nasal cannula therapy
heart rate variability
Time Frame: baseline and 1 week after high flow nasal cannula therapy
measured by QHRV system (Medeia Ltd.)
baseline and 1 week after high flow nasal cannula therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

November 19, 2019

First Submitted That Met QC Criteria

November 21, 2019

First Posted (Actual)

November 22, 2019

Study Record Updates

Last Update Posted (Actual)

November 22, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG2H0011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Apnea, Obstructive

Clinical Trials on high flow nasal cannula ventilation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe