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

Muhammad

Status: Completed

Conditions: Intracerebral Hemorrhage

Treatments: Device: Nasogastric Tube Feeding; Device: Intermittent Oro-esophageal Tube Feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT06304051

Naochuxue-IOE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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118 participants in 2 patient groups

Intermittent Oro-esophageal Tube Feeding

Active Comparator group

Description:

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.

Treatment:

Device: Intermittent Oro-esophageal Tube Feeding

Nasogastric Tube

Active Comparator group

Description:

This group was provided with nutrition support by the indwelling nasogastric tube. The entire feeding process strictly followed the standardized procedure for nasogastric feeding.

Treatment:

Device: Nasogastric Tube Feeding