Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06199778
Status:
TERMINATED
Last Update Posted:
2024-03-05
First Post:
2023-12-15
Brief Title:
Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patients With Tracheostomy
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 Patients With Tracheostomy
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:
STBI
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 n50 or the control group with Nasogastric tube feeding n48 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 n50 or the control group with Nasogastric tube feeding n48 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