PUSH-IT Continuing Enteral Feeds for Tracheostomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Feeds continued, Feeds held.
- Who it may be relevant to
- Registry conditions: Tracheostomy Complication, Critical Illness, Nutritional Deficiency. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prevent Unnecessary Surgeon Holds of Ingestions for Tracheostomy (PUSH-IT)
Overview
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.
Detailed 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.
Interventions
- Other Feeds continued
Enteral feeds are continued up until time of surgery - Other Feeds held
Enteral feeds are stopped 6 or more hours before surgery
Primary outcome measures
- Rate of aspiration pneumonia [Time frame: Over 7 days from the time of tracheostomy]
Secondary outcome measures (1)
- Volume of tube feed delivery [Time frame: From day of consent to completion of study which is 7 days from the time of tracheostomy.]
Eligibility criteria
Inclusion criteria
- 18 years or older
- admitted to the intensive care unit (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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 6 centers
- Nuvance Health - Danbury Hospital — Danbury
- St. Mary's Medical Center — West Palm Beach
- HCA Research Medical Center — Kansas City
- Erie County Medical Center (University at Buffalo) — Buffalo
- Lehigh Valley Health Network — Allentown
- University of South Carolina Sch of Medicine /Prisma Health Richland — Columbia
Identifiers
NCT: NCT05906472 · STUDY 00005099