Critical Illness Clinical Trial
Official title:
Prevent Unnecessary Surgeon Holds of Ingestions for Tracheostomy (PUSH-IT)
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Erie County Medical Center (University at Buffalo) | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
State University of New York at Buffalo |
United States,
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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