Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431048
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-28
First Post:
2024-05-16
Brief Title:
No DIET Trial Dogmatic Interruption of Enteral NuTrition
Sponsor:
Jeffrey Coughenour
Organization:
University of Missouri-Columbia
Study Overview
Official Title:
No DIET Trial Dogmatic Interruption of Enteral NuTrition
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is currently limited guidance on when to hold nutritional supplementation through for patients who are receiving tube feeding undergoing surgical procedures This study aims to investigate which time would be the best to stop nutrition if at all before undergoing a surgical procedure
Detailed Description:
The risk for malnutrition-associated complications is high for patients in the trauma- surgical- and neurological intensive care units Patients with persistent neurologic impairment often require nutritional supplementation through a variety of naso-enteral or surgical feeding tubes such as percutaneous endoscopic gastrostomy PEG tubes In patients with a protected airway enteral nutrition has been reported to continue during invasive surgical procedures Nonetheless University Hospitals current SOC for holding enteral nutrition prior to undergoing surgical procedures under anesthesia is 8 hours However the current American Society of Anesthesiologists ASA guidelines do not make provision for inpatients receiving supplemental enteral nutrition Enteral nutrition contains protein fat and carbohydrates mimicking what patients would consume with a solid food meal Balancing the need of optimized nutrition in critically ill patients with an unprotected airway against the risk of aspiration during surgical procedures brings a need for clear guidance on when to hold enteral nutrition prior to undergoing a tracheostomy procedure
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