Clinical trial NCT06304051: Effect of Intermittent Oral Enteral Nutrition Tube in Tracheostomized Patients With Intracerebral Hemorrhage
Official title: Comparative Study of Effect of Intermittent Oral Enteral Nutrition Tube in Tracheostomized Patients With Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracerebral Hemorrhage
Lead sponsor: Ahmadu Bello University Teaching Hospital
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of cases of successful extubation
timeFrame: day 30
Secondary outcomes:
measure: Body mass index
timeFrame: day 1 and day 30
measure: Serum albumin level
timeFrame: day 1 and day 30
measure: Hemoglobin level
timeFrame: day 1 and day 30
measure: Clinical Pulmonary Infection Score
timeFrame: day 1 and day 30
Other outcomes:
Locations:
city: Huabei
country: China
facility: Fu shu afi. Hos.
city: Huaibei
country: China
facility: Mingzhou Hos.
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Doctor
role: STUDY_CHAIR
References: