Ventilation Modalities and Acute Ischemic Stroke

NCT05323266 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2023-03-22

No results posted yet for this study

Summary

Acute ischemic stroke is the second leading cause of death and disability, and it is also one of the main reasons for the high cost of health care. The major risk factors for stroke are hypertension, atrial fibrillation, and smoking, which are the main intervention targets for primary stroke prevention. Although these recognized risk factors have been adequately treated, there are also significant differences in stroke incidence and outcome in the population. Sleep apnea is a common complication of acute ischemic stroke, characterized by upper airway obstruction and obstructive sleep apnea.

Nowadays, more studies are currently investigating CPAP to promote long-term neurological recovery, improve the ability to perform activities of daily living, and reduce the recurrence of cardiovascular disease in stroke patients. However, 25%-50% of patients with sleep apnea will refuse or be intolerant of ventilation with CPAP. High-flow nasal cannula (HFNC) therapy is a revolutionary non-invasive respiratory support option that is widely used in NICU worldwide. This trial aims to investigate the value of different ventilation methods in reducing the rate of pulmonary infections and tracheal intubation in stroke patients.

This trial is a prospective randomized cohort study, collecting patients with acute ischemic stroke in the intensive care unit of the Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology from 2022.05.01 to 2023.01.31. Participants who met the inclusion criteria were subjected to polysomnography on the first day of admission, and those diagnosed with sleep apnea according to the diagnostic criteria for sleep apnea were randomly grouped. Participants were given different forms of oxygen therapy, such as usual care therapy (nasal cannula and facemask), nasal continuous positive airway pressure (nCPAP), and HFNC oxygen therapy. After one week of observation, the investigators evaluated whether there were differences in the rate of tracheal intubation and pulmonary infection between the groups, as well as the length of hospitalization, hospital costs, and neurological recovery. All enrolled patients were followed up 1 month after discharge.

Conditions

  • Acute Ischemic Stroke
  • Sleep Apnea, Obstructive

Interventions

DEVICE

Nasal Continuous Positive Airway Pressure (nCPAP)

The two main interventions in this study were Nasal continuous positive airway pressure (nCPAP) and high-flow nasal cannula (HFNC) in patients with acute stroke. Nasal continuous positive airway pressure (nCPAP) is a way of ventilation completed in a non-invasive ventilator. In this study, the nasal mask is mainly used to replace the traditional oral and nasal mask.

DEVICE

High-Flow Nasal Cannula (HFNC)

The high-flow nasal cannula (HFNC), as another oxygen therapy, is also used as an intervention in this study to study the effect of early prognosis in patients with acute ischemic stroke.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Jinnong Zhang, MD · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-01-08
Completion
2023-02-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05323266 on ClinicalTrials.gov