- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06328946
The Impact of Different Feeding Modes on Patients With Intracerebral Hemorrhage
The Impact of Different Feeding Modes on Patients With Intracerebral Hemorrhage: Improving Clinical Outcomes and Safety
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lavie Ce
- Phone Number: 15333866454
- Email: zengxizdyfy@126.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intermittent Oro-esophageal Tube Feeding+Basic treatment
The patients were provided with 1) basic treatment including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control. For the observation group, the nasogastric tube was removed, and Intermittent oro-esophageal tube feeding was initiated for nutrition support within 4 hours after completing the admission assessment, following the standard Intermittent oro-esophageal tube feeding procedure. |
including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control
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.
|
Active Comparator: Nasogastric Tube Feeding+Basic treatment
The patients were provided with 1) basic treatment including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control. Patients in the control group were provided with nutrition support by the indwelling nasogastric tube. The entire feeding process strictly followed the standardized procedure for nasogastric feeding. |
including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of cases of successful extubation
Time Frame: day 1 and 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
|
day 1 and day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
day 1 and day 30
|
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
|
day 1 and day 30
|
Concentration of Serum albumin
Time Frame: day 1 and day 30
|
Serum albumin was recorded via blood routine test.(Alb,
g/L)
|
day 1 and day 30
|
Concentration of Hemoglobin
Time Frame: day 1 and day 30
|
Hemoglobin was recorded via blood routine test.(Hb,
mg/L)
|
day 1 and day 30
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nieto Luis, Site Coordinator of United Medical Group
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IOE intracerebral hemorrhage
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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