Aspiration PneumoniaNCT07508293
Continuous Enteral Feeding Until Tracheostomy and Aspiration Risk
An observational study of Aspiration Pneumonia and Tracheostomy, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspiration Pneumonia, Tracheostomy, Mechanical Ventilation
- What is being tested?
- Continuous enteral feeding and Fasting
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2022to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mimarsinan Mah. Emniyet Cad. 16310 Yıldırım/Bursa
Bursa, Bursa, 16310
About this study
Official title: 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.
Read the 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
- Being tested
- Continuous enteral feeding, Fasting
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous enteral feedingOther
Continuation of enteral nutrition without routine interruption until tracheostomy preparation, as per routine ICU practice.
FastingOther
Discontinuation of enteral nutrition for 6-8 hours prior to tracheostomy, in accordance with conventional pre-procedural fasting practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of aspiration pneumonia
Occurrence of aspiration pneumonia within 72 hours after percutaneous tracheostomy, defined based on clinical, radiological, and laboratory findings.
Measured: Within 72 hours after tracheostomy
Secondary outcomes (8)
Fraction of inspired oxygen (FiO₂)
FiO₂ measured within the early post-procedural period after percutaneous tracheostomy.
Measured: Within 24 hours after tracheostomy
Arterial partial pressure of oxygen (PaO₂)
PaO₂ measured within the early post-procedural period after percutaneous tracheostomy.
Measured: 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.
Measured: 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.
Measured: From ICU admission to ICU discharge, assessed up to 60 days
Intensive care unit mortality
Death occurring during the intensive care unit stay.
Measured: 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.
Measured: 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.
Measured: From hospital admission until hospital discharge or death, up to hospital discharge
Hospital mortality
Death occurring during the index hospitalization.
Measured: From hospital admission until hospital discharge or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start16 Dec 2022
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aspiration PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilkay Ceylan, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508293
- Sponsor's protocol ID
- 2011-KAEK-25 2022/11-11
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Ekin S, Gulen D, Ceylan I, Ozyaprak B, Korkmaz HA, Kilicarslan N. Impact of pre-tracheostomy continuous enteral feeding on aspiration pneumonia risk and clinical outcomes: a prospective observational study. BMC Pulm Med. 2026 Jul 28;26(1):450. doi: 10.1186/s12890-026-04548-w.
PubMed 42839232
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pre-Tracheostomy Continuous Enteral Feeding on Aspiration Pneumonia Risk and Clinical Outcomes: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07508293
- Acronym / sponsor ID
- 2011-KAEK-25 2022/11-11
- Conditions
- Aspiration Pneumonia, Tracheostomy, Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Continuous Enteral Feeding | – | Other: Continuous enteral feedingPatients who continued enteral nutrition without routine interruption until tracheostomy preparation, according to standard clinical practice in the intensive care unit. |
| Group 2: Fasting | – | Other: FastingPatients whose enteral nutrition was discontinued for 6-8 hours prior to tracheostomy, in accordance with conventional pre-procedural fasting practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous enteral feedingContinuation of enteral nutrition without routine interruption until tracheostomy preparation, as per routine ICU practice. | Other | Group 1: Continuous Enteral Feeding |
| FastingDiscontinuation of enteral nutrition for 6-8 hours prior to tracheostomy, in accordance with conventional pre-procedural fasting practice. | Other | Group 2: Fasting |
Primary outcome
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.
8 secondary outcomes
Fraction of inspired oxygen (FiO₂)
Time frame: Within 24 hours after tracheostomy
Arterial partial pressure of oxygen (PaO₂)
Time frame: Within 24 hours after tracheostomy
Procedure-related complications
Time frame: During procedure and within 72 hours after tracheostomy
Intensive care unit length of stay
Time frame: From ICU admission to ICU discharge, assessed up to 60 days
Intensive care unit mortality
Time frame: From ICU admission to ICU discharge, assessed up to 60 days
Lactate
Time frame: Baseline to 24 hours after tracheostomy
Hospital length of stay
Time frame: From hospital admission until hospital discharge or death, up to hospital discharge
Hospital mortality
Time frame: From hospital admission until hospital discharge or death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Derived from this study: PubMed 42839232Ekin S, Gulen D, Ceylan I, Ozyaprak B, Korkmaz HA, Kilicarslan N. Impact of pre-tracheostomy continuous enteral feeding on aspiration pneumonia risk and clinical outcomes: a prospective observational study. BMC Pulm Med. 2026 Jul 28;26(1):450. doi: 10.1186/s12890-026-04548-w.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspiration Pneumonia and Tracheostomy, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of aspiration pneumonia (time frame: Within 72 hours after tracheostomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07508293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.