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NCT Number: NCT07508293

Continuous Enteral Feeding Until Tracheostomy and Aspiration Risk

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mimarsinan Mah. Emniyet Cad. 16310 Yıldırım/Bursa

Bursa, 16310, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Treatment and study plan

Continuous enteral feeding

Other

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

Fasting

Other

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

Primary outcomes

  1. Incidence of aspiration pneumonia

    Time frame: Within 72 hours after tracheostomy

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

Secondary outcomes

  1. Fraction of inspired oxygen (FiO₂)

    Time frame: Within 24 hours after tracheostomy

    FiO₂ measured within the early post-procedural period after percutaneous tracheostomy.

  2. Arterial partial pressure of oxygen (PaO₂)

    Time frame: Within 24 hours after tracheostomy

    PaO₂ measured within the early post-procedural period after percutaneous tracheostomy.

  3. Procedure-related complications

    Time frame: 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.

  4. Intensive care unit length of stay

    Time frame: 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.

  5. Intensive care unit mortality

    Time frame: From ICU admission to ICU discharge, assessed up to 60 days

    Death occurring during the intensive care unit stay.

  6. Lactate

    Time frame: Baseline to 24 hours after tracheostomy

    Change in arterial lactate level measured during the first 24 hours after tracheostomy.

  7. Hospital length of stay

    Time frame: 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.

  8. Hospital mortality

    Time frame: From hospital admission until hospital discharge or death

    Death occurring during the index hospitalization.

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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