Optimizing Early Nutrition Support in Severe Stroke-2

Trophic Enteral Feeding Combined With Supplemental Parenteral Nutrition Treatment in Patients With Severe Stroke (OPENS-2): a Multicentre, Prospective, Randomised, Open-label, Blinded-endpoint Trial

Post stroke pneumonia (PSP) is one of the common early complications of stroke. Post-stroke infections, in general, are associated with less favorable neurologic outcomes. Aspiration is one of the most feared complications of enteral nutrition and can lead to the occurrence of pneumonia. Severe stroke patients are at high risk for aspiration due to some factors such as the reduced level of consciousness, inability to protect the airway and so on. The purpose of this study is to explore the ideal nutrition support strategy for patient with acute severe stroke to help reduce the incidence of PSP and improve the prognosis.

Study Overview

• Status: Recruiting
• Conditions: Dysphagia; Acute Stroke; Severe Stroke
• Intervention / Treatment: Procedure: Full enteral feeding; Procedure: Trophic enteral feeding combined with supplemental parenteral nutrition

Detailed Description

As one of the most common complication of stroke, some studies showed that post-stroke pneumonia (PSP) in stroke patients requiring intensive care is associated with an increase of ICU length of stay and hospital mortality and poorer functional outcomes in survivors. The peak period of PSP is within the first week after stroke. Aspiration and poor nutritional status are important factors leading to pneumonia in stroke patients. Compared with full enteral nutrition (EN), initial trophic enteral feeding was associated with less gastrointestinal intolerance and could reduce the rate of regurgitation. However, trophic enteral feeding could not meet the daily caloric needs and hypocaloric enteral nutrition might be associated with increased mortality. This study is designed to explore whether initial trophic enteral nutrition combined with supplemental parenteral nutrition (SPN) can help reduce the incidence of PSP and improve the prognosis in severe patients with stroke.

This study will enroll 546 severe stroke patients who meet the inclusion criteria. Upon admission to the ICU, patients will be randomly assigned at a 1:1 ratio into groups of full enteral feeding (controlled) and trophic enteral feeding combined with supplemental parenteral feeding (experimented) for 7 days.

• Study Type: Interventional
• Enrollment (Estimated): 546
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Wen Jiang, Ph.D; Phone Number: 86-029-84771319; Email: jiangwen@fmmu.edu.cn
• Study Contact Backup: Name: Xuan Wang, MD; Phone Number: 86-029-84773664; Email: 786369892@qq.com

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 404100
      • Recruiting
      • Chongqing University Three Gorges Hospital
      • Contact: Shengli Chen; Phone Number: 86-13896226960; Email: csl2271487396@163.com
    • Chongqing, Chongqing Municipality, China
      • Recruiting
      • Daping Hospital, The Third Military Medical University
      • Contact: Meng Zhang
  • Gansu
    • Lanzhou, Gansu, China
      • Recruiting
      • Gansu Provincal Central Hospital
      • Contact: Rong Yin
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
      • Contact: Lixin Wang
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Suyue Pan
  • Guizhou
    • Guiyang, Guizhou, China, 550000
      • Recruiting
      • The Affiliated Hospital of Guizhou Medical University
      • Contact: Mingyao You; Phone Number: 86-13639091084; Email: 553542599@qq.com
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • First Affiliated Hospital of Zhengzhou University
      • Contact: Wenjing Deng
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Tongji Hospital
      • Contact: Furong Wang
  • Hunan
    • Changsha, Hunan, China
      • Not yet recruiting
      • The First Hospital of Changsha City
      • Contact: Hong Tan
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Recruiting
      • The Second Affiliated Hospital of Nanchang University
      • Contact: Wei Huang; Phone Number: 86-13677080198; Email: 563095625@qq.com
  • Ningxia
    • Yinchuan, Ningxia, China, 750000
      • Recruiting
      • General Hospital of Ningxia Medical University
      • Contact: Xueping Zhang; Phone Number: 86-13639503586; Email: 1257204074@qq.com
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Recruiting
      • The First Affiliated Hospital Of Xi'an Jiaotong University
      • Contact: Kang Huo; Phone Number: 86-15202971941; Email: huokang8204@xjtu.edu.cn
    • Xi'an, Shaanxi, China
      • Recruiting
      • The First Affiliated Hospital of Xi'an Medical University
      • Contact: Bei Zhang
    • Xi'an, Shaanxi, China
      • Recruiting
      • Xi'an No.3 Hospital
      • Contact: Mingze Chang
    • Xi'an, Shaanxi, China, 710000
      • Not yet recruiting
      • Tangdu Hospital
      • Contact: Jun Guo, PhD
    • Xi'an, Shaanxi, China, 710000
      • Not yet recruiting
      • Xi'an Central Hospital
      • Contact: Zhengli Di, PhD
    • Xi'an, Shaanxi, China
      • Recruiting
      • Department of Neurology, Xijing Hospital
      • Contact: Wen Jiang, Ph.D; Phone Number: 86-029-84771319; Email: jiangwen@fmmu.edu.cn
    • Xi'an, Shaanxi, China
      • Not yet recruiting
      • Shannxi Provincal People's Hospital
      • Contact: Hua Lv
    • Xi'an, Shaanxi, China
      • Recruiting
      • Xi'an Gaoxin Hospital
      • Contact: Yi Jia; Phone Number: +86 13891996727; Email: 13891996727@163.com
    • Xi'an, Shaanxi, China, 710000
      • Recruiting
      • Shaanxi Second Provincal People's Hospital
      • Contact: Dong Huang; Phone Number: 86-13759902540; Email: 421136173@qq.com
    • Xianyang, Shaanxi, China
      • Recruiting
      • The First People's Hospital of Xianyang
      • Contact: Liping Yu
    • Xianyang, Shaanxi, China, 712000
      • Recruiting
      • Xianyang Hospital, Yan'an University
      • Contact: Wen Liu; Phone Number: 86-18740505535; Email: 174461442@qq.com
    • Yulin, Shaanxi, China
      • Not yet recruiting
      • Yulin No.1 Hospital
      • Contact: Yongfeng Huang
    • Yulin, Shaanxi, China
      • Not yet recruiting
      • Yulin No.2 Hospital
      • Contact: Xue Li
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • The Second Hospital of Shandong University
      • Contact: Wei Shang
    • Jinan, Shandong, China
      • Not yet recruiting
      • Qilu Hospital of Shangdong University
      • Contact: Qinzhou Wang
    • Jinan, Shandong, China
      • Recruiting
      • The PLA 960 Hospital
      • Contact: Huaiqiang Hu
    • Liaocheng, Shandong, China, 252000
      • Recruiting
      • Liaocheng People's Hospital
      • Contact: Xinyuan Shang; Phone Number: 86-15098430653; Email: xinyuanshang@126.com
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830000
      • Recruiting
      • People's Hospital of Xinjiang Uygur Autonomous Region
      • Contact: Hui Dang; Phone Number: 86-13899978881; Email: 64286542@qq.com
    • Ürümqi, Xinjiang, China, 830000
      • Recruiting
      • The Second Affiliated Hospital of Xinjiang Medical University
      • Contact: Xiaobei Wang; Phone Number: 86-17699055500; Email: 694624699@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age≥18 years
2. Definite diagnosis of acute stroke (GCS ≤12 or NIHSS≥11)
3. The randomized nutritional treatment could be initiated up to 72 hours after symptom onset.
4. Any cases of profiles #3 through 5 in Water Swallowing Test or with disorder of consciousness.
5. Plan to receive nutritional support treatment for at least 7 days.
6. Informed consent.

Exclusion Criteria:

1. Receiving parenteral nutrition support
2. Contraindications of enteral nutrition
3. Complicated with the disease which only have life expectancy < 7 days
4. Admission with infection signs
5. Dementia or severe disability (mRS>4) before stroke
6. Antibiotics were used within the previous 7 days
7. Subarachnoid hemorrhage, cerebral arteriovenous malformation
8. Presence of coexisting medical conditions that could interfere with outcome assessment and/or follow-up (a. advanced cancer; b. severe pulmonary dysfunction [forced expiratory volume in 1 second < 50% or/and moderate to severe acute lung injury (PaO2/FiO2)<200mmHg]; c. cardiac insufficiency (NYHA class > I; cardiac structural and/or functional abnormalities such as EF< 50%, abnormal cardiac chamber enlargement, moderate/severe ventricular hypertrophy, or moderate/severe valvular stenosis); d. Severe liver failure [Child-Pugh score≥7]; e. Severe renal failure [glomerular filtration rate ≤30mL/min or serum creatinine ≥4mg/dL]
9. Currently participating in other clinical trial
10. Pregnant woman
11. Patient who is considered highly likely not to adhere to the study treatment or follow-up protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Full enteral feeding; Patients will receive full enteral feeding through nasogastric tube or nasointestinal tube.	Procedure: Full enteral feeding; The caloric goal of the first day is one-third of caloric requirements, the second day is half of caloric requirements, the third day is 70-100% and sustained for 1 week. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day. Enteral nutrition is given through nasogastric tube or nasointestinal tube.
Experimental: Trophic enteral feeding combined with supplemental parenteral nutrition; Patients will receive trophic enteral feeding combined with supplemental parenteral feeding.	Procedure: Trophic enteral feeding combined with supplemental parenteral nutrition; The caloric goal of the first day is one-third of caloric requirements, the second day is half of caloric requirements, the third day is 70-100% and sustained for 1 week. Patients will receive the trophic enteral feeding with a caloric target of 500kcal/d (20-35ml/h), and the remaining calories are supplemented by parenteral nutrition. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of post stroke pneumonia	up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time from randomisation to the onset of the post stroke pneumonia		up to 7 days
Daily calorie delivery		up to 7 days
Daily protein delivery		up to 7 days
The incidence of gastrointestinal complications	Vomiting, diarrhea, gastric retention, gastrointestinal bleeding	up to 7 days
The use of prokinetic agents	The usage rate of prokinetic agents	up to 7 days
The occurrence of infections	The rate and onset time of infections from randomisation to ICU discharge	1 day of ICU discharge
The length of ICU stay		1 day of ICU discharge
Mortality	from randomisation to all cause death during ICU stay.	1 day of ICU discharge
The All-cause mortality rate	from randomisation to all cause death at 28 days	28 days after enrollment
Cardiac failure	The incidence of cardiac failure from randomisation to ICU discharge	1 day of ICU discharge
Tracheotomy	The incidence of tracheotomy from randomisation to ICU discharge	1 day of ICU discharge
Mechanical ventilation	The incidence of mechanical ventilation from randomisation to ICU discharge	1 day of ICU discharge
Continuous renal replacement therapy	The incidence of continuous renal replacement therapy from randomisation to ICU discharge	1 day of ICU discharge
The use of vasoactive agents	The usage rate of vasoactive agents from randomisation to ICU discharge	1 day of ICU discharge
Deep venous thrombosis	The incidence of deep venous thrombosis from randomisation to ICU discharge	1 day of ICU discharge
The score of National Institute of Health stroke scale at ICU discharge	National Institute of Health stroke scale, with scores ranging from 0 (normal function) to 42 (functional impairment) was used to evaluate the impairment caused by a stroke.	1 day of ICU discharge
Glasgow Coma Scale at ICU discharge	Glasgow Coma Scale,with scores ranging from 3 (no response) to 15 (normal response), was used to grade the conscious state.	1 day of ICU discharge
modified Rankin scale at ICU discharge	modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.	1 day of ICU discharge
Insulin utilization	Insulin utilization during the first 7 days post-randomization	up to 7 days
modified Rankin scale	modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke, including ordinal mRS, excellent outcome (mRS 0-1), and functional independence (mRS 0-2)	90 days after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite endpoint of all-cause mortality and post-stroke pneumonia	Hierarchical composite endpoint of all-cause mortality and post-stroke pneumonia within 90 days	90 days after randomization
Composite endpoint of all-cause mortality and post-stroke pneumonia	Hierarchical composite endpoint of all-cause mortality and post-stroke pneumonia within 7 days	7 days after randomization
Time from randomization to the first occurrence of either all-cause death or post-stroke pneumonia	Time from randomization to the first occurrence of either all-cause death or post-stroke pneumonia within 90 days	90 days after randomization

Collaborators and Investigators

• Sponsor: Wen Jiang-3
• Collaborators: Xijing Hospital; Xi'an Central Hospital; Tongji Hospital; Qilu Hospital of Shandong University; First Affiliated Hospital Xi'an Jiaotong University; Shaanxi Provincial People's Hospital; Tang-Du Hospital; The Second Hospital of Shandong University; Xi'an Gaoxin Hospital; Xi'an No.3 Hospital; First People's Hospital of Xianyang; Yulin No.1 Hospital; Yulin No.2 Hospital; The Second Affiliated Hospital of Guangzhou University of Chinese Medicine; Nanfang Hospital, Southern Medical University; PLA 960 Hospital; Daping Hospital, The Third Military Medical University (Army Medical University); First Hospital Affiliated to Zhengzhou University; Gansu Provincial Central Hospital; The First Hospital of Changsha City

Publications and helpful links

General Publications

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• McClave SA, DeMeo MT, DeLegge MH, DiSario JA, Heyland DK, Maloney JP, Metheny NA, Moore FA, Scolapio JS, Spain DA, Zaloga GP. North American Summit on Aspiration in the Critically Ill Patient: consensus statement. JPEN J Parenter Enteral Nutr. 2002 Nov-Dec;26(6 Suppl):S80-5. doi: 10.1177/014860710202600613.
• Harvey SE, Parrott F, Harrison DA, Bear DE, Segaran E, Beale R, Bellingan G, Leonard R, Mythen MG, Rowan KM; CALORIES Trial Investigators. Trial of the route of early nutritional support in critically ill adults. N Engl J Med. 2014 Oct 30;371(18):1673-84. doi: 10.1056/NEJMoa1409860. Epub 2014 Oct 1.
• Cohen DL, Roffe C, Beavan J, Blackett B, Fairfield CA, Hamdy S, Havard D, McFarlane M, McLauglin C, Randall M, Robson K, Scutt P, Smith C, Smithard D, Sprigg N, Warusevitane A, Watkins C, Woodhouse L, Bath PM. Post-stroke dysphagia: A review and design considerations for future trials. Int J Stroke. 2016 Jun;11(4):399-411. doi: 10.1177/1747493016639057. Epub 2016 Mar 22.
• Heidegger CP, Berger MM, Graf S, Zingg W, Darmon P, Costanza MC, Thibault R, Pichard C. Optimisation of energy provision with supplemental parenteral nutrition in critically ill patients: a randomised controlled clinical trial. Lancet. 2013 Feb 2;381(9864):385-93. doi: 10.1016/S0140-6736(12)61351-8. Epub 2012 Dec 3.
• Westendorp WF, Nederkoorn PJ, Vermeij JD, Dijkgraaf MG, van de Beek D. Post-stroke infection: a systematic review and meta-analysis. BMC Neurol. 2011 Sep 20;11:110. doi: 10.1186/1471-2377-11-110.
• National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.
• Meisel A, Smith CJ. Prevention of stroke-associated pneumonia: where next? Lancet. 2015 Nov 7;386(10006):1802-4. doi: 10.1016/S0140-6736(15)00127-0. Epub 2015 Sep 3. No abstract available.
• Wilson RD. Mortality and cost of pneumonia after stroke for different risk groups. J Stroke Cerebrovasc Dis. 2012 Jan;21(1):61-7. doi: 10.1016/j.jstrokecerebrovasdis.2010.05.002. Epub 2010 Jun 17.
• Kishore AK, Vail A, Chamorro A, Garau J, Hopkins SJ, Di Napoli M, Kalra L, Langhorne P, Montaner J, Roffe C, Rudd AG, Tyrrell PJ, van de Beek D, Woodhead M, Meisel A, Smith CJ. How is pneumonia diagnosed in clinical stroke research? A systematic review and meta-analysis. Stroke. 2015 May;46(5):1202-9. doi: 10.1161/STROKEAHA.114.007843. Epub 2015 Apr 9.
• Suda S, Aoki J, Shimoyama T, Suzuki K, Sakamoto Y, Katano T, Okubo S, Nito C, Nishiyama Y, Mishina M, Kimura K. Stroke-associated infection independently predicts 3-month poor functional outcome and mortality. J Neurol. 2018 Feb;265(2):370-375. doi: 10.1007/s00415-017-8714-6. Epub 2017 Dec 16.
• Finlayson O, Kapral M, Hall R, Asllani E, Selchen D, Saposnik G; Canadian Stroke Network; Stroke Outcome Research Canada (SORCan) Working Group. Risk factors, inpatient care, and outcomes of pneumonia after ischemic stroke. Neurology. 2011 Oct 4;77(14):1338-45. doi: 10.1212/WNL.0b013e31823152b1. Epub 2011 Sep 21.
• de Montmollin E, Ruckly S, Schwebel C, Philippart F, Adrie C, Mariotte E, Marcotte G, Cohen Y, Sztrymf B, da Silva D, Bruneel F, Gainnier M, Garrouste-Orgeas M, Sonneville R, Timsit JF; OUTCOMEREA Study Group. Pneumonia in acute ischemic stroke patients requiring invasive ventilation: Impact on short and long-term outcomes. J Infect. 2019 Sep;79(3):220-227. doi: 10.1016/j.jinf.2019.06.012. Epub 2019 Jun 22.
• Suntrup-Krueger S, Kemmling A, Warnecke T, Hamacher C, Oelenberg S, Niederstadt T, Heindel W, Wiendl H, Dziewas R. The impact of lesion location on dysphagia incidence, pattern and complications in acute stroke. Part 2: Oropharyngeal residue, swallow and cough response, and pneumonia. Eur J Neurol. 2017 Jun;24(6):867-874. doi: 10.1111/ene.13307. Epub 2017 Apr 27.
• Al-Khaled M. The multifactorial etiology of stroke-associated pneumonia. J Neurol Sci. 2019 May 15;400:30-31. doi: 10.1016/j.jns.2019.02.042. Epub 2019 Mar 12. No abstract available.
• Jabbar A, Chang WK, Dryden GW, McClave SA. Gut immunology and the differential response to feeding and starvation. Nutr Clin Pract. 2003 Dec;18(6):461-82. doi: 10.1177/0115426503018006461.
• Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.
• Uozumi M, Sanui M, Komuro T, Iizuka Y, Kamio T, Koyama H, Mouri H, Masuyama T, Ono K, Lefor AK. Interruption of enteral nutrition in the intensive care unit: a single-center survey. J Intensive Care. 2017 Aug 4;5:52. doi: 10.1186/s40560-017-0245-9. eCollection 2017.
• Altintas ND, Aydin K, Turkoglu MA, Abbasoglu O, Topeli A. Effect of enteral versus parenteral nutrition on outcome of medical patients requiring mechanical ventilation. Nutr Clin Pract. 2011 Jun;26(3):322-9. doi: 10.1177/0884533611405790. Epub 2011 Apr 29.
• Shi J, Wei L, Huang R, Liao L. Effect of combined parenteral and enteral nutrition versus enteral nutrition alone for critically ill patients: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Oct;97(41):e11874. doi: 10.1097/MD.0000000000011874.
• Zhao J, Yuan F, Song C, Yin R, Chang M, Zhang W, Zhang B, Yu L, Jia Y, Ma Y, Song Y, Wang C, Song C, Wang X, Shang L, Yang F, Jiang W; OPENS Trial Investigators. Safety and efficacy of three enteral feeding strategies in patients with severe stroke in China (OPENS): a multicentre, prospective, randomised, open-label, blinded-endpoint trial. Lancet Neurol. 2022 Apr;21(4):319-328. doi: 10.1016/S1474-4422(22)00010-2. Epub 2022 Feb 24.
• Compher C, Bingham AL, McCall M, Patel J, Rice TW, Braunschweig C, McKeever L. Guidelines for the provision of nutrition support therapy in the adult critically ill patient: The American Society for Parenteral and Enteral Nutrition. JPEN J Parenter Enteral Nutr. 2022 Jan;46(1):12-41. doi: 10.1002/jpen.2267. Epub 2022 Jan 3.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: August 11, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Dysphagia; pneumonia; Acute Stroke; trophic feeding; Severe Stroke; supplemental parenteral nutrition
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Digestive System Diseases; Gastrointestinal Diseases; Lung Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Stroke; Pneumonia; Deglutition Disorders
• Other Study ID Numbers: XJLL-KY-20222214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No