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NCT Number: NCT06255353

Effect of Different Feeding Modes in Intracerebral Hemorrhage

This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are:

Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.

Participants will be divided into two groups randomly, with different nutritional support respectively.

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Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Hospital, Xingxiang, China

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About this study

Safe and efficient enteral nutrition support for tracheostomized patients with intracerebral hemorrhage continues to be a challenge. Nasogastric tube feeding has been the mainstay in China but has a significant risk of adverse events. Intermittent oro-esophageal tube feeding is an established enteral nutrition mode that can be used to replace Nasogastric tube feeding. This study reports the clinical effect of Intermittent oro-esophageal tube feeding vs Nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage receiving basic medical treatment and comprehensive rehabilitation therapy.

However, in the field of intracerebral hemorrhage combined with tracheostomy, research on Intermittent oro-esophageal tube feeding is still relatively limited. Therefore, this study was carried out to explore the clinical effect of Intermittent oro-esophageal tube feeding vs. Nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage, mainly on nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit, and intervention-related adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • meeting the diagnostic criteria for Intracerebral Hemorrhage.
  • with placement of a tracheotomy tube.
  • requiring enteral nutrition support.
  • age over 18 years.
  • able to cooperate with treatment and questionnaire investigation.

Exclusion criteria

  • combined with tumors in the head, neck, esophagus, or gastrointestinal tract
  • an abnormal structure observed in the oral, pharyngeal, nasal regions or esophagus
  • with unstable vital signs or severe dysfunction of organs including heart, liver, lungs, or kidneys
  • with severe hemorrhagic disease or bleeding tendency;
  • with contraindications for enteral nutrition
  • with dysphagia caused by non-stroke-related reasons in the past

Treatment and study plan

Intermittent Oro-esophageal Tube Feeding

Device

The observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube Feeding according to the following procedure: Before each feeding, inside and outside of the tube was cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm. However, the specific depth should be evaluated based on patients' feedback and adjusted accordingly. After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation. Then, the feeding was to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding.

Basic treatment

Behavioral

including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control

Nasogastric Tube Feeding

Device

The control group was given enteral nutritional support with Nasogastric Tube Feeding according to the relevant guidelines. Within 4 hours after admission, the placement of the feeding tube was conducted by professional medical staffs and after intubation, the tube was secured to the patient's cheek with medical tape. The feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements. The feeding content was formulated by the nutritionists based on the patient's condition and relevant guidelines to reach the energy demand as 20-25 kcal/kg/day and protein supplementation of 1.2-2.0 g/kg/day for both two groups. For patients with limited tube feeding compliance, we made appropriate adjustments to ensure that they were not at risk of severe malnutrition as much as possible.

Primary outcomes

  1. Number of cases of successful extubation

    Time frame: day 30

    The Number of cases of successful extubation for both groups was recorded and compared. The parameters or criteria for extubation were: 1) stable clinical condition and a respiratory rate of 12-22 breaths per minute. 2) strong coughing ability and minimal airway secretions. 3) after completing a trial of tracheostomy tube capping, patients showed no fever, dyspnea, or asthma within 72 hours. Additionally, their blood oxygen saturation remained above 95% and normal oxygen partial pressure was observed

Secondary outcomes

  1. Body mass index

    Time frame: day 1 and day 30

    Weight and height will be combined to report Body mass index in kg/m^2

  2. Serum albumin

    Time frame: day 1 and day 30

    Serum albumin was recorded via blood routine test.(Alb, g/L)

  3. Hemoglobin

    Time frame: day 1 and day 30

    Hemoglobin was recorded via blood routine test.(Hb, mg/L)

  4. Clinical Pulmonary Infection Score

    Time frame: day 1 and day 30

    The Clinical Pulmonary Infection Score was recruited for evaluation, with specific assessment indicators such as body temperature, white blood cell count, respiratory secretions, chest X-rays, oxygenation index. The total scores ranged from 0 to 12, with a higher score indicated a more severe pulmonary infection

  5. National Institutes of Health Stroke Scale

    Time frame: day 1 and day 30

    We use the National Institutes of Health Stroke Scale. The total scores could range between 0-42. Higher scores indicate more severe deficits.

Sponsors and collaborators

Lead sponsor

Zeng Changhao

Other

Registry information

Official study title

Effect of Different Feeding Modes in Intracerebral Hemorrhage: Improving Clinical Outcomes and Safety

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2024
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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