Effect of Different Feeding Modes in Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06255353
• Other study ID #: IOE-Naochuxue-xin
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: People's Hospital of Zhengzhou University
• Contact: Qianyun Lu, Master
• Phone: 15333866454
• Email: luqianyun[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Device:
• Intermittent Oro-esophageal Tube Feeding
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.

Behavioral:
• Basic treatment
including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control

Device:
• Nasogastric Tube Feeding
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.

Locations

Country	Name	City	State
Korea, Republic of	Center Rehabilitation Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Zeng Changhao

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cases of successful extubation	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	day 30
Secondary	Body mass index	Weight and height will be combined to report Body mass index in kg/m^2	day 1 and day 30
Secondary	Serum albumin	Serum albumin was recorded via blood routine test.(Alb, g/L)	day 1 and day 30
Secondary	Hemoglobin	Hemoglobin was recorded via blood routine test.(Hb, mg/L)	day 1 and day 30
Secondary	Clinical Pulmonary Infection Score	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	day 1 and day 30