Comparison of Oral and Nasal Tube Feeding on Stroke-related Dysphagia

NCT06301633 | Completed

• 1 other identifier: IOE-STROKE
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Penetration-Aspiration Scale

  Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. The scores ranged 1 point to 8 points. As the level increased, the severity of dysphagia also increased.

  day 1 and day 15

Secondary Outcomes (6)

• Body weight

  day 1 and day 15

• total protein

  day 1 and day 15

• albumin

  day 1 and day 15

• Yale pharyngeal residue severity rating scale

  day 1 and day 15

• Patient health questionnaire-9

  day 1 and day 15

Study Arms (2)

Intermittent Oro-esophageal Tube Feeding+comprehensive rehabilitation therapy

EXPERIMENTAL

Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation therapy. The observation group was provided the support of enteral nutrition by Intermittent Oro-esophageal Tube Feeding.

Device: Intermittent Oro-esophageal Tube Feeding; Behavioral: comprehensive rehabilitation therapy

Nasogastric Tube Feeding+comprehensive rehabilitation therapy

ACTIVE COMPARATOR

Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation. The observation group was provided the support of enteral nutrition by Nasogastric Tube Feeding.

Device: Nasogastric Tube Feeding; Behavioral: comprehensive rehabilitation therapy

Interventions

Intermittent Oro-esophageal Tube Feeding DEVICE

The specific procedure was as follows: the infant was placed in a semi-recumbent or sitting position with the head fixed. Before each feeding, the infant's oral and nasal secretions were to be cleared. An intermittent oro-esophageal tube was appropriately lubricated with water on the head part. The professional medical staff held the tube and slowly inserted it through one side of the mouth into the upper part of the esophagus. The depth of insertion depended on the patient's age and height. After each feeding, the tube was immediately removed, and the patient was held upright for at least 30 minutes in case of reflux.

Intermittent Oro-esophageal Tube Feeding+comprehensive rehabilitation therapy

Nasogastric Tube Feeding DEVICE

Nasogastric Tube Feeding were used for feeding to provide nutritional support. Each feeding was administered by a nurse using the infant's mother's breast milk through the tube. The amount of each feeding varied from 20 to 100 ml depending on the age of the infant, with feedings given every 2 to 3 hours, approximately 10 times per day. The duration of each feeding procedure ranged from 10 to 20 minutes. The total daily intake ranged from 200 to 1000 ml. Each tube was kept indwelling for 5 to 7 days. When the tube needed to be replaced, it was removed after the last feeding of a day and a new tube was to be inserted through the other nostril on the following morning to continue the nutritional support.

Nasogastric Tube Feeding+comprehensive rehabilitation therapy

comprehensive rehabilitation therapy BEHAVIORAL

Both groups were given comprehensive rehabilitation therapy. The main intervention measures included: 1) non-invasive ventilator treatment, generally at least once every night and typically not exceeding continuous daily usage.; 2) attention to feeding and sleeping positions, with a recommended sleeping position of lateral recumbent and the head of the bed raised by 20-30°; 3) swallowing function training, such as tongue muscle stretching training, assisted anterior jaw protrusion training, lemon ice stimulation to the soft palate, pharyngeal wall, etc., generally 5 days per week, twice per day, 5-20 minutes each time; 4) pulmonary ultrashort wave therapy, generally at least 2-3 times a week, and not more than once a day; 5) physical therapy, such as intensive training for gross motor functions including lifting the head, turning over, sitting, crawling, standing, etc., generally 3-5 days per week, 1-2 times per day, 5-20 min each time.

Intermittent Oro-esophageal Tube Feeding+comprehensive rehabilitation therapy; Nasogastric Tube Feeding+comprehensive rehabilitation therapy

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;
• meeting the diagnostic criteria of stroke;
• any degree of dysphagia at admission;
• steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
• transferred out within three weeks of hospitalization in the neurology department.

You may not qualify if:

• complicated with other neurological diseases;
• damaged mucosa or incomplete structure in nasopharynx;
• tracheostomy tube plugged;
• unfeasible to the support of parenteral nutrition;
• simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.

Sponsors & Collaborators

• Muhammad: lead

Study Sites (1)

The 1st afi. Hos.

Zhenzhou, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: January 31, 2022
• Primary Completion: December 10, 2023
• Study Completion: December 30, 2023
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)