Effect of Intermittent Oro-esophageal Tube vs Nasogastric Tube in Tracheostomized Patients With Intracerebral Hemorrhage

NCT06203561 | Terminated DMC

• 1 other identifier: 2022-KY-0132
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage transferred to the Department of Rehabilitation Medicine of 4 hospitals in China between January 2023 to June 2023. 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. .

Conditions

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Body mass index

  day 1 and day 30

• Serum albumin

  day 1 and day 30

• Hemoglobin

  day 1 and day 30

• Clinical Pulmonary Infection Score

  day 1 and day 30

Study Arms (2)

The observation group

EXPERIMENTAL

The patients were provided with 1) basic treatment including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control, and 2) comprehensive rehabilitation therapy including respiratory tract management, care for tracheotomy tube, comprehensive training for hemiplegic limbs, swallowing function training, pulmonary function training, and acupuncture. 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.

Behavioral: Basic treatment; Behavioral: comprehensive rehabilitation therapy; Device: Intermittent Oro-esophageal Tube Feeding

The control group

ACTIVE COMPARATOR

The patients were provided with 1) basic treatment including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control, and 2) comprehensive rehabilitation therapy including respiratory tract management, care for tracheotomy tube, comprehensive training for hemiplegic limbs, swallowing function training, pulmonary function training, and acupuncture. 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.

Behavioral: Basic treatment; Behavioral: comprehensive rehabilitation therapy; Device: Nasogastric Tube Feeding

Interventions

Basic treatment BEHAVIORAL

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

The control group; The observation group

comprehensive rehabilitation therapy BEHAVIORAL

including respiratory tract management, care for tracheotomy tube, comprehensive training for hemiplegic limbs, swallowing function training, pulmonary function training, and acupuncture.

The control group; The observation group

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.

The observation group

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.

The control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, (Generally with a Mini-Mental State Examination (MMSE) score ≥ 24) .

You may not qualify if:

• 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; 5) with contraindications for enteral nutrition
• with dysphagia caused by non-stroke-related reasons in the past

Sponsors & Collaborators

• Zeng Changhao: lead

Study Sites (1)

Zheng da yi fu yuan hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group located in Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 12, 2024
• Study Start: January 17, 2023
• Primary Completion: June 5, 2023
• Study Completion: June 12, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)