Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179550
Status:
TERMINATED
Last Update Posted:
2024-03-15
First Post:
2023-12-02
Brief Title:
Intermittent Oro-esophageal Tube Feeding on Cerebral Small Vessel Disease Patients With Dysphagia
Sponsor:
Zeng Changhao
Organization:
Peoples Hospital of Zhengzhou University
Study Overview
Official Title:
A Randomized Controlled Study to Explore the Clinical Effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding on Cerebral Small Vessel Disease Patients With Dysphagia
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
ethical issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CSVD
Brief Summary:
Nasogastric tube feeding NGT has been widely used in cerebral small vessel disease CSVD patients with dysphagia but has a significant risk of complications Intermittent Oro-esophageal Tube Feeding IOE is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy This study aims to explore the clinical effect of IOE vs NGT on CSVD Patients with Dysphagia Compared to NGT IOE as an enteral nutrition support mode in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy showed advantages in improvement in dysphagia nutritional status ADL QOL pneumonia and adverse events which should be considered as the preferred approach
Detailed Description:
Nasogastric tube feeding NGT has been widely used in cerebral small vessel disease CSVD patients with dysphagia but has a significant risk of complications Intermittent Oro-esophageal Tube Feeding IOE is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy This study aims to explore the clinical effect of IOE vs NGT on CSVD Patients with Dysphagia
This was a randomized controlled study with 60 CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy Patients enrolled were randomly divided into the observation group with IOE n30 and the control group with NGT n30 At admission and after treatment Video Fluoroscopic Swallowing Study VFSS and Functional Oral Intake Scale FOIS body mass index BMI serum albumin Alb and hemoglobin Hb Modified Barthel Index MBI and World Health Organization Quality of Life Assessment Instrument Brief Version WHOQOL-BREF were recruited to assess and compare dysphagia nutritional status activities of daily living ADL and quality of life QOL The incidence of pneumonia was recorded and compared
This was a randomized controlled study with 60 CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy Patients enrolled were randomly divided into the observation group with IOE n30 and the control group with NGT n30 At admission and after treatment Video Fluoroscopic Swallowing Study VFSS and Functional Oral Intake Scale FOIS body mass index BMI serum albumin Alb and hemoglobin Hb Modified Barthel Index MBI and World Health Organization Quality of Life Assessment Instrument Brief Version WHOQOL-BREF were recruited to assess and compare dysphagia nutritional status activities of daily living ADL and quality of life QOL The incidence of pneumonia was recorded and compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Zhengzhou University | REGISTRY | kfkioecsvd | None |