Shortened Preoperative Fasts in ICU

Not Applicable

Completed

• Conditions: Intubated ICU Patients
• Interventions: Other: shortened fast

• Registration Number: NCT03031379
• Lead Sponsor: Montefiore Medical Center

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 Timeline

• Status Verified: 2012-02
• Study Start: 2012-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2017-01-22
• Study First Submitted QC: 2017-01-22
• Study First Posted: 2017-01-25
• Last Update Submitted: 2018-04-18
• Last Update Posted: 2018-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• intubated ICU patient undergoing tracheotomy, receiving enteral nutrition, adult, proxy available for consent

Exclusion Criteria

• pregnant, <18yo, cannot tolerate enteral feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B - shortened fast	shortened fast	fast of only 45 minutes prior to incision

Primary Outcome Measures

Name	Time	Method
Calories delivered	72 hours	Calories delivered before and after surgery

Secondary Outcome Measures

Name	Time	Method
Aspiration	5 days	intraoperative or postoperative aspiration

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States