Continuous Enteral Feeding Until Tracheostomy and Aspiration Risk

NCT07508293 | Completed

• 1 other identifier: 2011-KAEK-25 2022/11-11
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aspiration Pneumonia; Tracheostomy; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• Incidence of aspiration pneumonia

  Occurrence of aspiration pneumonia within 72 hours after percutaneous tracheostomy, defined based on clinical, radiological, and laboratory findings.

  Within 72 hours after tracheostomy

Secondary Outcomes (8)

• Fraction of inspired oxygen (FiO₂)

  Within 24 hours after tracheostomy

• Arterial partial pressure of oxygen (PaO₂)

  Within 24 hours after tracheostomy

• Procedure-related complications

  During procedure and within 72 hours after tracheostomy

• Intensive care unit length of stay

  From ICU admission to ICU discharge, assessed up to 60 days

• Intensive care unit mortality

  From ICU admission to ICU discharge, assessed up to 60 days

Study Arms (2)

Group 1: Continuous Enteral Feeding

Patients who continued enteral nutrition without routine interruption until tracheostomy preparation, according to standard clinical practice in the intensive care unit.

Other: Continuous enteral feeding

Group 2: Fasting

Patients whose enteral nutrition was discontinued for 6-8 hours prior to tracheostomy, in accordance with conventional pre-procedural fasting practices.

Other: Fasting

Interventions

Continuous enteral feeding OTHER

Continuation of enteral nutrition without routine interruption until tracheostomy preparation, as per routine ICU practice.

Group 1: Continuous Enteral Feeding

Fasting OTHER

Discontinuation of enteral nutrition for 6-8 hours prior to tracheostomy, in accordance with conventional pre-procedural fasting practice.

Group 2: Fasting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult (≥18 years) mechanically ventilated patients admitted to the intensive care units of Bursa Yüksek İhtisas Training and Research Hospital who were scheduled for elective bedside percutaneous tracheostomy. Patients were managed according to routine ICU enteral nutrition practices and included those receiving either continuous enteral feeding until tracheostomy preparation or conventional pre-procedural fasting.

You may qualify if:

• Age ≥18 years
• Mechanically ventilated patients in the intensive care unit
• Receiving enteral nutrition
• Scheduled for elective percutaneous tracheostomy
• No radiologically confirmed active pneumonia at baseline
• No diagnosis of acute respiratory distress syndrome (ARDS)
• No ventilator-associated pneumonia at the time of tracheostomy

You may not qualify if:

• ) Early death after ICU admission 2-) Inability to receive enteral nutrition (e.g., ileostomy, colostomy, severe gastrointestinal pathology) 3-) Clinically significant gastric intolerance (persistent vomiting, abdominal distension, feeding intolerance) 4-) Hemodynamic instability requiring inotropic support 5-) Refusal of participation by patient or legal representative 6-) Pre-procedural enteral nutrition interruption between 1-6 hours 7-) Missing or incomplete clinical data

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Mimarsinan Mah. Emniyet Cad. 16310 Yıldırım/Bursa

Bursa, Bursa, 16310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pneumonia, Aspiration

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: April 2, 2026
• Study Start: December 16, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)