Ventilation Modalities and Acute Ischemic Stroke

NCT05323266 | Completed DMC

• 1 other identifier: NICU0110WXR
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acute Ischemic Stroke; Sleep Apnea; Apnea-Hypopnea Index

Outcome Measures

Primary Outcomes (3)

• Tracheal Intubation Rate

  To observe the change of tracheal intubation rate between different groups after 1 week of ventilation in patients with acute ischemic stroke using different ventilation methods after admission.

  one week

• Pulmonary Infection Status

  To observe the change in the rate of pulmonary infection between different groups after 1 week of ventilation in patients with acute ischemic stroke using different ventilation methods after admission

  one week

• 28-day mortality rate

  Patients with acute ischemic stroke were treated with different modes of ventilation after admission to observe whether there was any difference in 28-day mortality among different groups of patients.

  28 days

Secondary Outcomes (6)

• National Institute of Health stroke scale (NIHSS)

  one week

• Barthel Index

  1 month

• Sleep Apnea Symptoms

  one week

• Time of Hospitalization

  From date of randomization until the date of death from any cause or discharge, whichever came first, assessed up to 3 months.

• Cost of Hospitalization

  From date of randomization until the date of death from any cause or discharge, whichever came first, assessed up to 3 months.

Study Arms (2)

Nasal Continuous Positive Airway Pressure (nCPAP)

EXPERIMENTAL

Nasal Continuous Positive Airway Pressure is the main mode of oxygen supply observed in this study, and this group of patients only use this oxygen supply mode to receive oxygen therapy after stroke.

Device: Nasal Continuous Positive Airway Pressure (nCPAP)

High-Flow Nasal Cannula (HFNC)

EXPERIMENTAL

NasalContinuousPositiveAirwayPressure is another oxygen supply mode mainly observed in this study, and this group of patients only use this oxygen supply mode to receive oxygen therapy after stroke.

Device: High-Flow Nasal Cannula (HFNC)

Interventions

Nasal Continuous Positive Airway Pressure (nCPAP) DEVICE

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.

Nasal Continuous Positive Airway Pressure (nCPAP)

High-Flow Nasal Cannula (HFNC) DEVICE

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.

High-Flow Nasal Cannula (HFNC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Clinical diagnosis of acute ischemic stroke and sleep apnea (AHI≥5/hour)
• Definite cerebral infarct lesions on CT and MRI
• National Institutes of Health Stroke Score (NIHSS) baseline score of 2-20
• State of consciousness (Glasgow Coma Score of ≥9)
• Semi-quantitative cough strength score of ≥2.

You may not qualify if:

• Pre-existing obstructive sleep apnea
• Suspected sleep disorders other than sleep apnea (e.g., episodic sleeping sickness)
• Respiratory distress requiring mechanical ventilation
• Oxygen-dependent chronic obstructive pulmonary disease
• Pregnancy
• Intracranial hemorrhage
• Inability to use a nasal mask or mask (e.g., facial trauma)
• Patients who died within 24 h of admission
• History of other neurological disorders such as Parkinson's disease, neuro infection, neuromuscular disease patients
• Hospice care or comfort measures only
• Inability to provide informed consent
• Inability to provide valid information
• Suicidal ideation.

Sponsors & Collaborators

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

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

Related Publications (12)

• Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41. doi: 10.1056/NEJMoa043104.

  PMID: 16282178 BACKGROUND

• Redline S, Yenokyan G, Gottlieb DJ, Shahar E, O'Connor GT, Resnick HE, Diener-West M, Sanders MH, Wolf PA, Geraghty EM, Ali T, Lebowitz M, Punjabi NM. Obstructive sleep apnea-hypopnea and incident stroke: the sleep heart health study. Am J Respir Crit Care Med. 2010 Jul 15;182(2):269-77. doi: 10.1164/rccm.200911-1746OC. Epub 2010 Mar 25.

  PMID: 20339144 BACKGROUND

• Gottlieb E, Landau E, Baxter H, Werden E, Howard ME, Brodtmann A. The bidirectional impact of sleep and circadian rhythm dysfunction in human ischaemic stroke: A systematic review. Sleep Med Rev. 2019 Jun;45:54-69. doi: 10.1016/j.smrv.2019.03.003. Epub 2019 Mar 20.

  PMID: 30954762 BACKGROUND

• Tanayapong P, Kuna ST. Sleep disordered breathing as a cause and consequence of stroke: A review of pathophysiological and clinical relationships. Sleep Med Rev. 2021 Oct;59:101499. doi: 10.1016/j.smrv.2021.101499. Epub 2021 Apr 30.

  PMID: 34020180 BACKGROUND

• Lin HJ, Yeh JH, Hsieh MT, Hsu CY. Continuous positive airway pressure with good adherence can reduce risk of stroke in patients with moderate to severe obstructive sleep apnea: An updated systematic review and meta-analysis. Sleep Med Rev. 2020 Dec;54:101354. doi: 10.1016/j.smrv.2020.101354. Epub 2020 Jul 15.

  PMID: 32755811 BACKGROUND

• Parra O, Sanchez-Armengol A, Bonnin M, Arboix A, Campos-Rodriguez F, Perez-Ronchel J, Duran-Cantolla J, de la Torre G, Gonzalez Marcos JR, de la Pena M, Carmen Jimenez M, Masa F, Casado I, Luz Alonso M, Macarron JL. Early treatment of obstructive apnoea and stroke outcome: a randomised controlled trial. Eur Respir J. 2011 May;37(5):1128-36. doi: 10.1183/09031936.00034410. Epub 2010 Sep 16.

  PMID: 20847081 BACKGROUND

• Rochwerg B, Einav S, Chaudhuri D, Mancebo J, Mauri T, Helviz Y, Goligher EC, Jaber S, Ricard JD, Rittayamai N, Roca O, Antonelli M, Maggiore SM, Demoule A, Hodgson CL, Mercat A, Wilcox ME, Granton D, Wang D, Azoulay E, Ouanes-Besbes L, Cinnella G, Rauseo M, Carvalho C, Dessap-Mekontso A, Fraser J, Frat JP, Gomersall C, Grasselli G, Hernandez G, Jog S, Pesenti A, Riviello ED, Slutsky AS, Stapleton RD, Talmor D, Thille AW, Brochard L, Burns KEA. The role for high flow nasal cannula as a respiratory support strategy in adults: a clinical practice guideline. Intensive Care Med. 2020 Dec;46(12):2226-2237. doi: 10.1007/s00134-020-06312-y. Epub 2020 Nov 17.

  PMID: 33201321 BACKGROUND

• Yan H, Qinghua L, Mengyuan P, Yaoyu C, Long Z, Mengjie L, Xiaosong D, Fang H. High flow nasal cannula therapy for obstructive sleep apnea in adults. Sleep Breath. 2022 Jun;26(2):783-791. doi: 10.1007/s11325-021-02453-6. Epub 2021 Aug 12.

  PMID: 34383275 BACKGROUND

• Nakanishi N, Suzuki Y, Ishihara M, Ueno Y, Tane N, Tsunano Y, Itagaki T, Oto J. Effect of High-Flow Nasal Cannula on Sleep-disordered Breathing and Sleep Quality in Patients With Acute Stroke. Cureus. 2020 Jul 20;12(7):e9303. doi: 10.7759/cureus.9303.

  PMID: 32832300 BACKGROUND

• Ho CH, Chen CL, Yu CC, Yang YH, Chen CY. High-flow nasal cannula ventilation therapy for obstructive sleep apnea in ischemic stroke patients requiring nasogastric tube feeding: a preliminary study. Sci Rep. 2020 May 22;10(1):8524. doi: 10.1038/s41598-020-65335-z.

  PMID: 32444630 BACKGROUND

• Yeghiazarians Y, Jneid H, Tietjens JR, Redline S, Brown DL, El-Sherif N, Mehra R, Bozkurt B, Ndumele CE, Somers VK. Obstructive Sleep Apnea and Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2021 Jul 20;144(3):e56-e67. doi: 10.1161/CIR.0000000000000988. Epub 2021 Jun 21.

  PMID: 34148375 BACKGROUND

• Li Z, Pang M, Yu Y, Peng T, Hu Z, Niu R, Wang X, Zhang J. Effect of different ventilation modalities on the early prognosis of patients with sleep apnea after acute ischemic stroke---protocol for a prospective, open-label and randomised controlled trial. BMC Neurol. 2023 Jun 6;23(1):215. doi: 10.1186/s12883-023-03117-6.

  PMID: 37280508 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Jinnong Zhang, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical outcome assessors in this study were blinded, and blinding was not possible for participants, investigators and care providers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal medicine physician

Model Details: Patients with acute ischemic stroke were admitted to the Intensive Care Unit of the Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Patients were diagnosed with sleep apnea after polysomnography monitoring. They were divided into 3 groups according to the randomization principle, the usual care group (nasal cannula or mask), the nasal continuous positive airway pressure (nCPAP) group, and the high-flow nasal cannula (HFNC) group. In this study, nCPAP and HFNC were used as 2 different interventions in comparison to the usual care group.

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 12, 2022
• Study Start: May 1, 2022
• Primary Completion: January 8, 2023
• Study Completion: February 15, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Share individual participant data with other researchers at the end of the study for six months.
• Access Criteria: Researchers are interested in the results of this project or committed to improving the prognosis of patients with acute ischemic stroke release data on individual participants.

Locations

CN (1)