Effect of Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on Dysphagia Patients After Stroke

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• Stroke 7,286

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

Lead sponsor

Zeng Changhao is the lead sponsor of 59 studies on the registry; 26 are open to participants now.

Study arms

• Experimental
  the observation group

  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

• Active comparator
  the control group

  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

• DeviceIntermittent Oro-esophageal Tube Feeding

  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.

• DeviceNasogastric Tube Feeding

  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.

• Behavioralcomprehensive rehabilitation therapy

  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.

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.

   Time frame: day 1 and day 15

Secondary outcomes

1. Body weight

   Body weight measurement of the infants was conducted by the same nurse according to the relevant standards.

   Time frame: day 1 and day 15

2. Nutritional status-total protein

   The relevant indicators include total protein (TP, g/L) from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning.

   Time frame: day 1 and day 15

3. Nutritional status-albumin

   The relevant indicators include albumin (ALB, g/L)from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning.

   Time frame: day 1 and day 15

4. Yale pharyngeal residue severity rating scale

   The Yale pharyngeal residue severity rating scale was recruited for assessment, of which the result would be divided into 5 levels (1, no residue; 2, the covered pharyngeal mucosa; 3, mild residue, less than 50%; 4, moderate residue, more than 50%; 5, severe residue, spillage from laryngeal vestibule observed).As the level increased, the severity of dysphagia also increased.

   Time frame: day 1 and day 15

5. Patient health questionnaire-9

   The depression of the patients was evaluated with the patient health questionnaire-9. The scores ranged 0-27. As the scores increased, the severity of depression also increased.

   Time frame: day 1 and day 15

6. Swallowing Quality of Life questionnaire

   Swallowing Quality of Life questionnaire was used to evaluate the quality of life, which consists of 44 items and divided into 11 main domains, including: overall satisfaction, understanding, diet, hydration, communication, respiratory issues, postoperative recovery, social impact, mental health, saliva control, and appearance. The maximum rough score was 220 points, which was converted into a standard percentage system in our study. As the scores increased, the quality of life was better.

   Time frame: day 1 and day 15

Individual participant data

Plan to share: No