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Stroke Associated PneumoniaSottopdaspwbNCT07345078

Study on the Treatment of Post-stroke Dysphagia and Stroke-associated Pneumonia With Bronchoscopy

A study testing Tracheoscopy suction and bronchoalveolar lavage in people with Stroke Associated Pneumonia and Non Severe Ischemic Stroke, run by The First People's Hospital of Zunyi at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Select 50 non-severe ischemic SAP patients with swallowing difficulties in our intensive care unit and randomly divide them into two group.The control group was given conventional anti-infective drugs, expectorants, and suctioning with a suction tube. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Tracheoscopy suction and bronchoalveolar lavage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 Sep 2019to 30 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meets the diagnostic criteria for acute stroke and is clearly diagnosed through head MRI or CT examination.
  • According to the Wada drinking water test, there is indeed difficulty swallowing.
  • Pneumonia occurs within 72 hours after stroke, confirmed by chest imaging examination, and meets the diagnostic criteria for stroke-related pneumonia.
  • Clear consciousness, stable vital signs, and able to cooperate with bronchial examination.

Who cannot join

  • The condition is critical, with severe hemiplegia and mental disorders that cannot tolerate bronchoscopy treatment.
  • Combined lung tumors, open pulmonary tuberculosis, coagulation dysfunction, severe cardiovascular and cerebrovascular diseases, severe heart, liver, and kidney dysfunction, and pulmonary infection before stroke.
  • Not willing to undergo bronchoscopy examination.
  • Individuals with previous esophageal functional structural abnormalities.
  • Disagree with participating researchers.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Zunyi First People's Hospital

    Zunyi, Guizhou, 562400

Other trials in China

About this study

Select 50 non-severe ischemic SAP patients with swallowing difficulties in our intensive care unit and randomly divide them into two group.The control group was given conventional anti-infective drugs, expectorants, and suctioning with a suction tube. The treatment group was treated with fiberoptic bronchoscopy suction and bronchoalveolar lavage, while the drug treatment was the same as the control group. Compare heart rate, respiration, blood pressure, blood oxygen saturation, arterial blood gas analysis, procalcitonin, interleukin-32, lung function, C-reactive protein, clinical pulmonary infection score (CPIS), swallowing difficulty assessment scale, and adverse reactions between two groups.

Read the detailed description

Stroke-associated pneumonia (SAP) is one of the most common respiratory complications of acute stroke, which occurs in about 4% to 9% of patients after stroke. Among patients with acute ischemic stroke who receive treatment in the neurological intensive care unit and those who need feeding through a nasogastric tube, the incidence rate of stroke-associated pneumonia is higher (21% and 44%, respectively). Compared with patients without pneumonia, stroke-related pneumonia patients have a higher mortality rate and poorer long-term prognosis. Pneumonia is the most common cause of fever within 48 hours after acute stroke and also the most common complication within 2-4 weeks after supratentorial ischemic infarction. In addition, retrospective data indicate that pneumonia and respiratory diseases are the most common causes of hospitalization among stroke survivors in the first five years after ischemic stroke. The independent risk factors for hospitalized pneumonia are age over 65 years, articulation disorders or speechlessness caused by aphasia, severe post-stroke disability, cognitive impairment, and swallowing difficulties. In an early prospective study, the risk factors for 124 acute stroke patients receiving treatment in the intensive care unit were mechanical ventilation, abnormal chest X-rays upon admission, and swallowing difficulties. Post-stroke aspiration pneumonia is usually caused by stroke-related swallowing difficulties (i.e., impaired swallowing motor and sensory mechanisms) or decreased consciousness leading to impaired cough reflex and glottal closure. Moreover, prophylactic use of antibiotics in acute stroke patients cannot reduce the incidence of post-stroke pneumonia or improve prognosis.

Dysphagia is a common symptom of end-stage illness, where a decline in swallowing function during the last weeks to months of life weakens people's desire and ability to eat. Dysphagia of solids and liquids is one of the most common symptoms in the last few days of life. Dysphagia can affect quality of life (such as socializing and communication), leading to nutritional and water intake disorders. Dysphagia is also a major susceptible inhalation condition and can cause pneumonia, and in some cases, even suffocation or death. Considering that food and nutrition are the central focus of social interaction, as well as people's general concern for the nutrition needed for health, swallowing disorders can also bring setbacks and pain to home caregivers and healthcare workers. In addition, for many end-stage disease patients, inability to swallow and/or disinterest in food may be a key symptom that prompts them to decide to give up treatment and end-of-life care. Dysphagia refers to difficulty swallowing food or liquids, including medications in liquid or pill form. Dysphagia after stroke may be caused by motor or sensory dysfunction in neural processes, which can lead to problems with eating certain types of food or liquids, or even inability to swallow at all. Patients may complain about food getting stuck in the upper digestive tract from the throat to the distal esophagus and experiencing coughing or suffocation while eating or drinking. Chronic swallowing difficulties can affect the efficiency of oral feeding, leading to physical weakness, decreased appetite, weight loss, dehydration, and malnutrition. In addition, airway protection or swallowing safety may also be threatened by swallowing disorders. Food or liquids may transfer into the trachea, causing inhalation, suffocation, or, in severe cases, suffocation. Inhalation Pneumonia is an infectious process caused by inhalation of oral and pharyngeal secretions colonized by pathogenic bacteria. Gram-negative Escherichia coli and anaerobic bacteria are the most common pathogenic microorganisms, while inhalation of sterile acidic gastric contents can also cause acute chemical damage to the lungs. Therefore, improving dysphagia after stroke is particularly important for the treatment of SAP, which can remove the etiology, significantly reduce the incidence rate of SAP, and improve the prognosis. Swallowing is not a random activity but a complex reflex activity that requires specific stimuli to trigger. Although swallowing can be initiated at will, the process of completing this action is a complex reflex activity. A simple swallowing movement requires coordination of 25 pairs of muscles in the mouth, pharynx, larynx, esophagus, and face, with the participation of at least 6 pairs of cranial nerves, language, and respiratory systems. Swallowing is a typical and complex reflex action that involves a series of sequential steps, each consisting of a series of activity processes, where the activity of the previous step can trigger the activity of the subsequent step. The receptors for swallowing activity are located in the soft palate, posterior pharyngeal wall, epiglottis, and esophagus. Their afferent nerves include fibers from the soft palate (5th and 9th pairs), posterior pharyngeal wall (9th pair), epiglottis (10th pair), and esophagus (10th pair of cranial nerves). The basic center is located in the medulla oblongata, and the efferent nerves are located in the 5th, 9th, 10th, 11th, and 12th pairs of cranial nerves. Their effector organs include muscle groups such as the tongue, throat, pharyngeal muscles, and esophagus. Every step of swallowing is interconnected and indispensable. After a stroke, if the lesion affects the medulla oblongata, swallowing and breathing difficulties may occur.

Domestic research mainly focuses on prevention of SAP-related risk factors, cluster nursing, rehabilitation training, and acupuncture and moxibustion treatment of traditional Chinese medicine, but there is no report on the treatment of dysphagia after stroke by tracheoscopy. Bedside bronchoscopy can clear airway secretions directly through the glottis, stimulate coughing and swallowing muscles to produce contraction movements, and play a positive role in preventing aspiration and relieving swallowing difficulties. Tracheoscopy can directly stimulate the trigeminal nerve of the soft palate, the glossopharyngeal nerve of the posterior pharyngeal wall, and the vagus nerve of the epiglottis, promoting the contraction movement of the chewing muscle group, suprahyoid muscle group, infrahyoid muscle group, facial muscle, tongue muscle, and soft palate muscle group, thereby training the swallowing muscle group, exercising swallowing function, improving swallowing disorders, and significantly reducing the incidence and mortality of SAP.

At present, there are no reports of bedside bronchoscopy for the treatment of post-stroke dysphagia and SAP at home and abroad. This study attempts to explore the application value and clinical safety of portable fiberoptic bronchoscopy (bronchoscope) in non-severe SAP dysphagia patients and evaluate whether bronchoscopy treatment can alleviate the symptoms of dysphagia in SAP patients and improve hypoxia, pulmonary infection, and SAP prognosis.

After obtaining the consent of the subjects, 50 non-severe ischemic SAP patients with swallowing difficulties in our intensive care unit were selected and randomly divided into a treatment group and a control group using a random number table method. The control group was given conventional anti-infective drugs, expectorants, and suctioning with a suction tube. The treatment group was treated with fiberoptic bronchoscopy suction and bronchoalveolar lavage, while the drug treatment was the same as the control group. Compare heart rate, respiration, blood pressure, blood oxygen saturation, arterial blood gas analysis, procalcitonin, interleukin-32, lung function, C-reactive protein, clinical pulmonary infection score (CPIS), swallowing difficulty assessment scale, and adverse reactions between two groups. Comparing the advantages of bronchoscopic sputum aspiration and bronchoalveolar lavage treatment for subjects, direct stimulation of the glottis and pharynx through bronchoscopy induces afferent impulses in neurons (V, VII, X, XII), triggering coughing and Pharyngeal muscle contraction enables pharyngeal muscle exercise, improves swallowing difficulties, reduces aspiration, gradually restores diet, and enhances body function Nurture and promote recovery.

Being tested
Tracheoscopy suction and bronchoalveolar lavage
Keywords
bronchoscope
Medical subject headings
Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tracheoscopy suction and bronchoalveolar lavageDevice

    Also called Tracheoscopy suction, bronchoalveolar lavage

    On the basis of the control group, the observation group received 1-2 sessions of bronchoscopy treatment, including suction, lavage, and medication injection under the microscope. Specific operating steps: Use atropine injection 0.5 mg combined with lidocaine injection 0.1 g nebulized inhalation for local anesthesia. The Olympus BF-P180 fiberoptic bronchoscope is routinely inserted through the nasal cavity and sequentially enters each level of bronchus to clean airway secretions under direct vision. Collect lavage fluid for bacterial culture and drug sensitivity testing. When the sputum is thick and difficult to aspirate, physiological saline can be used for lavage. Both groups are treated continuously for one week.

Study groups in NCT07345078
Study groupRoleWhat they receive
Control groupNo interventionThe control group received routine anti-infection and expectorant treatment and was given suctioning with a suction tube as needed, that is, suctioning at any time when breathing is difficult or there is a sound of phlegm in the airway.
Observation groupExperimentalThe observation group received 1-2 sessions of bronchoscopy treatment, including suction, lavage, and medication injection under the microscope. Two groups were treated continuously for one week.
Receives: Device: Tracheoscopy suction and bronchoalveolar lavage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NIHSS scores

    It is a standardized tool used to assess the degree of neurological deficits in patients with acute stroke, consisting of 15 items covering consciousness level, visual field, facial paralysis, limb movement, ataxia, sensory, language, and articulation disorders. The scoring range for each project is 0 to 4 points, with 0 indicating no defects and higher scores indicating more severe neurological deficits; The total score ranges from 0 to 42 points, with 0 indicating no neurological deficits and 42 indicating extremely severe deficits

    Measured: From enrollment to the end of treatment at 2 weeks.

  2. Acute Physiology and Chronic Health Evaluation (APACHE) II scores

    It includes three parts: acute physiology score (APS), chronic physiology score (CPS), and patient age score, with a total score of 0-71 points. The higher the score, the more severe the patient's condition, the worse the prognosis, and the higher the mortality rate

    Measured: From enrollment to the end of treatment at 2 weeks.

  3. CPIS scores

    Clinical Pulmonary Infection Scores

    Measured: From enrollment to the end of treatment at 2 weeks.

  4. Water Swallow Test scores

    Grade I: able to drink without coughing within 5 seconds; Grade II: No coughing after drinking twice or more; Grade III: Can be consumed in one go but accompanied by coughing; Grade IV: Drink twice or more with coughing; Grade V: Frequent coughing and inability to finish all drinks. Grade I indicates normal, Grade II indicates suspicious, and Grade III or above indicates abnormal.

    Measured: From enrollment to the end of treatment at 2 weeks.

  5. CRP

    C-reactive protein

    Measured: From enrollment to the end of treatment at 2 weeks.

  6. Length of hospital stay

    The length of hospital stay from enrollment to discharge

    Measured: From enrollment to the end of treatment at 4 weeks.

  7. PaO2

    Arterial partial pressure of oxygen

    Measured: From enrollment to the end of treatment at 2 weeks.

  8. Height

    Subject's height(m)

    Measured: From enrollment to the end of treatment at 1 week.

  9. Weight

    Subject's weight(Kg)

    Measured: From enrollment to the end of treatment at 1 week.

  10. BMI

    Body Mass Index (Report BMI in kg/m² by combining weight and height)

    Measured: From enrollment to the end of treatment at 1 week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2026
  2. Study start1 Sep 2019
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The control group was given conventional anti-infective drugs, expectorants, and suctioning with a suction tube. The treatment group was treated with fiberoptic bronchoscopy for sputum suction and bronchoalveolar lavage.
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07345078
Sponsor's protocol ID
HZ(2019)146
Acronym
Sottopdaspwb
Status last verified
Jan 2026
First submitted
26 Nov 2025
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: ICMJE journals and other team members involved in the research.

Questions about this trial

What is this clinical trial studying?

A study testing Tracheoscopy suction and bronchoalveolar lavage in people with Stroke Associated Pneumonia and Non Severe Ischemic Stroke, run by The First People's Hospital of Zunyi at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NIHSS scores (time frame: From enrollment to the end of treatment at 2 weeks.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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