Aspiration Pneumonia, Mechanical Ventilation, Tracheostomy
Conditions
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.
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.
Interventions
Continuation of enteral nutrition without routine interruption until tracheostomy preparation, as per routine ICU practice.
OTHERFasting
Discontinuation of enteral nutrition for 6-8 hours prior to tracheostomy, in accordance with conventional pre-procedural fasting practice.
Sponsors
Bursa Yuksek Ihtisas Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of aspiration pneumonia | Within 72 hours after tracheostomy | Occurrence of aspiration pneumonia within 72 hours after percutaneous tracheostomy, defined based on clinical, radiological, and laboratory findings. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fraction of inspired oxygen (FiO₂) | Within 24 hours after tracheostomy | FiO₂ measured within the early post-procedural period after percutaneous tracheostomy. |
| Arterial partial pressure of oxygen (PaO₂) | Within 24 hours after tracheostomy | PaO₂ measured within the early post-procedural period after percutaneous tracheostomy. |
| Procedure-related complications | During procedure and within 72 hours after tracheostomy | Occurrence of complications related to percutaneous tracheostomy, including procedure-associated bleeding, hypotension, desaturation, subcutaneous emphysema, pneumothorax, or tube-related complications. |
| Intensive care unit length of stay | From ICU admission to ICU discharge, assessed up to 60 days | Length of stay in the intensive care unit, measured in days from ICU admission to ICU discharge or death. |
| Intensive care unit mortality | From ICU admission to ICU discharge, assessed up to 60 days | Death occurring during the intensive care unit stay. |
| Lactate | Baseline to 24 hours after tracheostomy | Change in arterial lactate level measured during the first 24 hours after tracheostomy. |
| Hospital length of stay | From hospital admission until hospital discharge or death, up to hospital discharge | Length of hospital stay, measured in days from hospital admission to hospital discharge or death. |
| Hospital mortality | From hospital admission until hospital discharge or death | Death occurring during the index hospitalization. |
Countries
Turkey (Türkiye)
Outcome results
None listed