Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06261281
Status:
WITHDRAWN
Last Update Posted:
2024-03-06
First Post:
2024-01-28
Brief Title:
Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patient
Sponsor:
Zeng Changhao
Organization:
Peoples Hospital of Zhengzhou University
Study Overview
Official Title:
A Randomized Controlled Study to Explore the Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patient
Status:
WITHDRAWN
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Ethical issue
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IOE-TBI
Brief Summary:
This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding or the control group with Nasogastric tube feeding for enteral nutrition support respectively Nutritional status complications decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared
Detailed Description:
The safe and effective nutrition support for severe traumatic brain injury patients with tracheostomy continues to be a challenge Nasogastric tube feeding has been the mainstream choice in China but with the risk of complications Intermittent Oro-esophageal Tube Feeding is an established modality of enteral nutrition support that can be used with routine treatment This study reports the clinical outcomes of Intermittent Oro-esophageal Tube Feeding vs nasogastric tube feeding in patients receiving routine treatment This was a multicenter randomized controlled study of 98 severe traumatic brain injury patients with tracheostomy Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding or the control group with Nasogastric tube feeding for enteral nutrition support respectively Nutritional status complications decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were 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