NCT07508293

Continuous Enteral Feeding Until Tracheostomy and Aspiration Risk

Impact of Pre-Tracheostomy Continuous Enteral Feeding on Aspiration Pneumonia Risk and Clinical Outcomes: A Prospective Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 91 (actual)
• Sponsor: Bursa Yuksek Ihtisas Training and Research Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective observational study evaluates whether continuing enteral feeding until tracheostomy affects aspiration pneumonia risk and early clinical outcomes in mechanically ventilated intensive care unit patients undergoing elective percutaneous tracheostomy. Patients are managed according to routine ICU practice and are observed in two groups: those who continue enteral feeding until tracheostomy preparation and those who undergo conventional 6-8-hour fasting before the procedure. The primary outcome is the incidence of aspiration pneumonia within 72 hours after tracheostomy. Secondary outcomes include respiratory parameters, arterial blood gas values, procedure-related complications, length of stay, and mortality. The study aims to determine whether routine fasting before tracheostomy provides additional clinical benefit or whether maintaining nutritional continuity may be a safe alternative in critically ill patients.

Detailed description

This prospective observational study was conducted in the intensive care units of Bursa Yüksek İhtisas Training and Research Hospital to evaluate the clinical impact of enteral nutrition management before elective bedside percutaneous tracheostomy in mechanically ventilated patients. In routine clinical practice, enteral feeding is often interrupted for several hours prior to tracheostomy due to concerns about aspiration risk; however, evidence supporting this approach is limited. In this study, patients were managed according to existing institutional practices and were observed in two groups based on enteral nutrition management strategy: continuation of enteral feeding until tracheostomy preparation or discontinuation of feeding 6-8 hours before the procedure. No randomization or intervention assignment was performed. The primary objective is to assess the incidence of aspiration pneumonia within the early post-procedural period. Secondary outcomes include respiratory parameters, arterial blood gas measurements, procedure-related complications, length of stay in the intensive care unit and hospital, and mortality. By comparing these two commonly used approaches, this study aims to determine whether routine pre-procedural fasting provides additional clinical benefit or whether maintaining enteral nutrition until tracheostomy is a safe and feasible alternative in critically ill patients. The findings may contribute to optimizing peri-procedural nutritional strategies and reducing unnecessary interruptions in enteral feeding in intensive care practice.

Conditions

• Aspiration Pneumonia
• Tracheostomy
• Mechanical Ventilation

Interventions

Type	Name	Description
OTHER	Continuous enteral feeding	Continuation of enteral nutrition without routine interruption until tracheostomy preparation, as per routine ICU practice.
OTHER	Fasting	Discontinuation of enteral nutrition for 6-8 hours prior to tracheostomy, in accordance with conventional pre-procedural fasting practice.

Timeline

• Start date: 2022-12-16
• Primary completion: 2023-12-01
• Completion: 2024-01-01
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

1 site across 1 country: Turkey (Türkiye)