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Effect of Intermittent Oro-esophageal Tube vs Nasogastric Tube in Tracheostomized Patients With Intracerebral Hemorrhage | Clinical Trials | Clareo Health

TERMINATEDNA

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

Comparative Study of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients With Intracerebral Hemorrhage: Improving Clinical Outcomes and Safety

NCT06203561•Zeng Changhao

View on ClinicalTrials.gov

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. .

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

Age

18 - No limit years

Sex

ALL

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, (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

Locations (1)

Zheng da yi fu yuan hospital

Zhengzhou, Henan, China

Key Dates

Start Date

January 17, 2023

Primary Completion Date

June 5, 2023

Completion Date

June 12, 2023

Last Updated

March 8, 2024

Enrollment

118

ACTUAL participants

Conditions

Intracerebral Hemorrhage

Interventions

Basic treatment

BEHAVIORAL

comprehensive rehabilitation therapy

BEHAVIORAL

Intermittent Oro-esophageal Tube Feeding

DEVICE

Nasogastric Tube Feeding

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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