Effect of Different Feeding Modes in Intracerebral Hemorrhage

Not Applicable

Recruiting

• Conditions: Intracerebral Hemorrhage

• Registration Number: NCT06255353
• Lead Sponsor: Zeng Changhao

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-13
• Study Start: 2024-02-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-02
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of cases of successful extubation	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 Outcome Measures

Name	Time	Method
Hemoglobin	day 1 and day 30	Hemoglobin was recorded via blood routine test.(Hb, mg/L)
Serum albumin	day 1 and day 30	Serum albumin was recorded via blood routine test.(Alb, g/L)
Clinical Pulmonary Infection Score	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
Body mass index	day 1 and day 30	Weight and height will be combined to report Body mass index in kg/m\^2

Trial Locations

Locations (1)

Center Rehabilitation Hospital; 🇰🇷 Seoul, Korea, Republic of