NCT03031379CompletedNot Applicable
Feasibility of Shortened Preoperative Fasts in Intubated ICU Patients Undergoing Tracheotomy
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Montefiore Medical Center
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Calories delivered
Study Overview
Brief Summary
Randomized controlled trial assessing the safety and benefits of shortening preoperative fasts on intubated ICU patients undergoing tracheotomy.
Detailed Description
Patients undergoing bedside tracheotomy in an ICU are enrolled and randomized into two groups. Arm A receive a standard fast of at least 6 hours. Arm B receive a shortened fast of only 45 minutes, just before the surgery begins. Patients will be monitored for aspiration, pneumonia and our ability to delivery better nutrition as a result of the intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •intubated ICU patient undergoing tracheotomy, receiving enteral nutrition, adult, proxy available for consent
Exclusion Criteria
- •pregnant, <18yo, cannot tolerate enteral feeding
Arms & Interventions
A - control
No Intervention
standard fast, at least 6 hours prior to tracheotomy
B - shortened fast
Experimental
fast of only 45 minutes prior to incision
Intervention: shortened fast (Other)
Outcomes
Primary Outcomes
Calories delivered
Time Frame: 72 hours
Calories delivered before and after surgery
Secondary Outcomes
- Aspiration(5 days)
Investigators
Study Sites (2)
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