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

NCT07345078 | Completed

• 1 other identifier: HZ（2019）146
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke Associated Pneumonia; Non Severe Ischemic Stroke; Dysphagia

Keywords

bronchoscope

Outcome Measures

Primary Outcomes (10)

• 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

  From enrollment to the end of treatment at 2 weeks.

• 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

  From enrollment to the end of treatment at 2 weeks.

• CPIS scores

  Clinical Pulmonary Infection Scores

  From enrollment to the end of treatment at 2 weeks.

• 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.

  From enrollment to the end of treatment at 2 weeks.

• CRP

  C-reactive protein

  From enrollment to the end of treatment at 2 weeks.

• Length of hospital stay

  The length of hospital stay from enrollment to discharge

  From enrollment to the end of treatment at 4 weeks.

• PaO2

  Arterial partial pressure of oxygen

  From enrollment to the end of treatment at 2 weeks.

• Height

  Subject's height（m）

  From enrollment to the end of treatment at 1 week.

• Weight

  Subject's weight（Kg）

  From enrollment to the end of treatment at 1 week.

• BMI

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

  From enrollment to the end of treatment at 1 week.

Study Arms (2)

Control group

NO INTERVENTION

The 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 group

EXPERIMENTAL

The 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.

Device: Tracheoscopy suction and bronchoalveolar lavage

Interventions

Tracheoscopy suction and bronchoalveolar lavage DEVICE

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.

Also known as: Tracheoscopy suction, bronchoalveolar lavage

Observation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First People's Hospital of Zunyi: lead

Study Sites (1)

Zunyi First People's Hospital

Zunyi, Guizhou, 562400, China

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 15, 2026
• Study Start: September 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)