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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05906472
Other study ID # STUDY 00005099
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 6, 2023
Est. completion date December 31, 2024

Study information

Verified date June 2023
Source State University of New York at Buffalo
Contact Eden Nohra, MD
Phone 3144439727
Email edennohra@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate nutrition administration in the time around the tracheostomy in patients with breathing tubes. The main questions it aims to answer are: - Will continuing nutrition up to the time of surgery (tracheostomy) decrease nutrition interruptions, thereby increasing food intake? - Does continuing nutrition up to the time of surgery increase instances of food going into the lungs or lung infections? Researchers will compare patients who have nutrition withheld 6 hours prior to surgery versus those who receive nutrition up until the time of surgery to see if there are differences in food intake, instances of food entering the lungs or lung infections.


Description:

Malnutrition is a significant problem in the critically ill, however with busy operating room schedules, we often find that feeds are interrupted repetitively prior to elective surgery. These interruptions are practiced based on the American Society of Anesthesiologist guidelines for fasting intervals for elective surgery. These guidelines, however, were not created for critically ill, intubated patients. The theoretical concern for an increased risk of aspiration with continuation of enteral feeds up to the time of surgery persists without supporting evidence. Thus, there is a need for a universal evidence-based guideline on perioperative enteral feeding to benefit critical care patients. To this end, the goal of the present study is to implement a protocol designed to decrease the interruption of enteral feeds in critical care patients undergoing tracheostomy and prospectively evaluate whether this leads to a quantitative increase in nutritional intake without increasing the risk of aspiration. Additionally, we hope that increasing quantitative nutrition may decrease morbidity especially in the small subset of patients where feed interruptions occur repetitively. If the aims of the project are achieved, the data obtained from this study will be used to create an evidence-based platform from which physicians can practice. This will end the anecdotal controversy regarding perioperative tube feed management for tracheostomy; thereby increasing quantitative nutrition and hopefully improving the care of critically ill patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years or older - admitted to the ICU - intubated and require tracheostomy Exclusion Criteria: - under 18 years - unable to obtain informed consent - deemed clinically brain dead within 7 days of enrollment - transitioned to comfort measures within 7 days of enrollment - Pregnant patients - Prisoners

Study Design


Intervention

Other:
Feeds continued
Enteral feeds are continued up until time of surgery
Feeds held
Enteral feeds are stopped 6 or more hours before surgery

Locations

Country Name City State
United States Erie County Medical Center (University at Buffalo) Buffalo New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of aspiration pneumonia To assess differences in rates of aspiration events, a log-rank test for differences in survival curves model will be used. Assuming proportional hazards and non-informative censoring, a cox-model will be used to estimate follow-up hazard ratios for development of aspiration pneumonia between the two groups of interest. Over 7 days from the time of tracheostomy
Secondary Volume of tube feed delivery We will compare the volume of tube feeds delivered daily between the two groups for the duration of the study. From day of consent to completion of study which is 7 days from the time of tracheostomy.
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