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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04173767
• Other study ID #: CMRPG2H0011
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: November 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Cerebral Infarction
• Deglutition Disorders
• Infarction
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital, Keelung	Keelung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	apnea-hypopnea index	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
Primary	oxyhemoglobin desaturation index	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	pulse wave velocity	velocity (m/s) measured by SphygmoCor CPV system	baseline and 1 week after high flow nasal cannula therapy
Secondary	heart rate variability	measured by QHRV system (Medeia Ltd.)	baseline and 1 week after high flow nasal cannula therapy