Effect of Intermittent Oral Enteral Nutrition Tube in Tracheostomized Patients With Intracerebral Hemorrhage

Comparative Study of Effect of Intermittent Oral Enteral Nutrition Tube in Tracheostomized Patients With 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.

Study Overview

• Status: Completed
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Device: Intermittent Oro-esophageal Tube Feeding; Device: Nasogastric Tube Feeding

Detailed Description

Safe and efficient enteral nutrition support for tracheostomized patients with intracerebral hemorrhage continues to be a challenge.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 Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Huabei, China
    • Fu shu afi. Hos.
  • Huaibei, China
    • Mingzhou Hos.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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 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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intermittent Oro-esophageal Tube Feeding; 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.	Device: Intermittent Oro-esophageal Tube Feeding; 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; This group was provided with nutrition support by the indwelling nasogastric tube. The entire feeding process strictly followed the standardized procedure for nasogastric feeding.	Device: Nasogastric Tube Feeding; 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, the investigators 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	The Number of tracheostomized patients 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	Weight and height will be combined to report Body mass index in kg/m^2	day 1 and day 30
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
Serum albumin level	Serum albumin was recorded via blood routine test.(Alb, g/L)	day 1 and day 30
Hemoglobin level	Hemoglobin was recorded via blood routine test.(Hb, mg/L)	day 1 and day 30

Collaborators and Investigators

• Sponsor: Muhammad
• Investigators: Study Chair: Nieto Luis, Doctor, Site Coordinator of United Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: Naochuxue-IOE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No