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

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.

Study Overview

• Status: Completed
• Conditions: Tracheostomy; Aspiration Pneumonia; Mechanical Ventilation
• Intervention / Treatment: Other: Continuous enteral feeding; Other: Fasting

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.

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Bursa
    • Bursa, Bursa, Turkey (Türkiye), 16310
      • Mimarsinan Mah. Emniyet Cad. 16310 Yıldırım/Bursa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

1. Age ≥18 years
2. Mechanically ventilated patients in the intensive care unit
3. Receiving enteral nutrition
4. Scheduled for elective percutaneous tracheostomy
5. No radiologically confirmed active pneumonia at baseline
6. No diagnosis of acute respiratory distress syndrome (ARDS)

7. No ventilator-associated pneumonia at the time of tracheostomy

   • Exclusion Criteria:

1-) 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Continuation of enteral nutrition without routine interruption until tracheostomy preparation, as per routine ICU practice.
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; Discontinuation of enteral nutrition for 6-8 hours prior to tracheostomy, in accordance with conventional pre-procedural fasting practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fraction of inspired oxygen (FiO₂)	FiO₂ measured within the early post-procedural period after percutaneous tracheostomy.	Within 24 hours after tracheostomy
Arterial partial pressure of oxygen (PaO₂)	PaO₂ measured within the early post-procedural period after percutaneous tracheostomy.	Within 24 hours after tracheostomy
Procedure-related complications	Occurrence of complications related to percutaneous tracheostomy, including procedure-associated bleeding, hypotension, desaturation, subcutaneous emphysema, pneumothorax, or tube-related complications.	During procedure and within 72 hours after tracheostomy
Intensive care unit length of stay	Length of stay in the intensive care unit, measured in days from ICU admission to ICU discharge or death.	From ICU admission to ICU discharge, assessed up to 60 days
Intensive care unit mortality	Death occurring during the intensive care unit stay.	From ICU admission to ICU discharge, assessed up to 60 days
Lactate	Change in arterial lactate level measured during the first 24 hours after tracheostomy.	Baseline to 24 hours after tracheostomy
Hospital length of stay	Length of hospital stay, measured in days from hospital admission to hospital discharge or death.	From hospital admission until hospital discharge or death, up to hospital discharge
Hospital mortality	Death occurring during the index hospitalization.	From hospital admission until hospital discharge or death

Collaborators and Investigators

• Sponsor: Bursa Yuksek Ihtisas Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: March 21, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Pneumonia, Aspiration; Angptl4 protein, mouse
• Other Study ID Numbers: 2011-KAEK-25 2022/11-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to the inclusion of sensitive patient information and institutional data protection policies. Data may be available from the corresponding author upon reasonable request and subject to ethical and institutional approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No