Clinical trial NCT06203561: Effect of Intermittent Oro-esophageal Tube vs Nasogastric Tube in Tracheostomized Patients With Intracerebral Hemorrhage
Official title: Comparative Study of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients With Intracerebral Hemorrhage: Improving Clinical Outcomes and Safety
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intracerebral Hemorrhage
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-12
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 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.

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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.

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

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; 5) with contraindications for enteral nutrition
* 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
timeFrame: day 1 and day 30
measure: Hemoglobin
timeFrame: day 1 and day 30
measure: Clinical Pulmonary Infection Score
timeFrame: day 1 and day 30
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zheng da yi fu yuan hospital
state: Henan
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: PRINCIPAL_INVESTIGATOR
References: