Critically IllNCT07222007
Induction Agent Choice With Early Mortality and Prognostic Outcomes in Critically Ill Patients
An observational study of Critically Ill and Intubation Complication, run by Zeliha Alicikus at 1 site in United States.
Trial summary
The aim of this retrospective cohort study is to compare the safety and efficacy of induction agents for tracheal intubation in critically ill adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Intubation Complication, Oxygenation
- What is being tested?
- induction type for intubation in ICU
- Type of treatment
- Surgery or procedure
- How many people
- 806 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2026to 1 Jul 2026
- 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: ICU admitted, critically ill patients The study population will include critically ill trauma patients aged 18 years and older who were admitted to the surgical intensive care unit
Who may be able to join
- Age ≥ 18 years
- Admission to the surgical ICU for critical care
- Administration of one of the studied induction agents
- Availability of complete clinical data
Who cannot join
- Age < 18 years
- Absence of documented induction agent administration
- Incomplete or missing medical records
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Jacksonville (Shands Hospital)
Jacksonville, Florida, 32209
About this study
Official title: Association of Induction Agent Choice With Early Mortality and Prognostic Outcomes in Critically Ill Patients: A Large-Scale Retrospective Cohort Analysis
The aim of this retrospective cohort study is to compare the safety and efficacy of induction agents for tracheal intubation in critically ill adult patients.
Read the detailed description
Endotracheal intubation is an accepted procedure to optimize oxygenation and ventilation and reduce the risk of aspiration for critically ill patients, essential for their management and survival across various settings, including prehospital care, emergency departments (EDs), and intensive care units (ICUs). Despite advancements, peri-intubation complications and hemodynamic instability, which are associated with increased mortality rates, remain a concern. These risks are exacerbated by pathophysiological factors in critically ill patients compared to those undergoing intubation in surgical settings .
A recent international, multicentre, prospective cohort (INTUBE) study of 2964 critically ill patients undergoing tracheal intubation in the ICU, emergency department, or inpatient wards in 29 countries across five continents reported that the most frequently used agents for induction were Propofol (41.5%), Midazolam (36.4%), Etomidate (17.8%), and Ketamine (14.2%).
The choice of induction agent for intubation may have the potential to minimise or exacerbate complication and mortality. Although considerable research has been carried out, critical central question concern which induction agent is most effective in minimizing cardiovascular instability during intubation. As Kotani and Risotto declared in their recent systematic review, the available findings are insufficient to support conclusive statements. Further studies are needed to identify the optimal agent and dosage, taking into account patient variability and concurrent therapeutic interventions.
Understanding the impact of induction agent selection in critically ill patients has the potential to guide clinical practice in emergency and intensive care settings. Identifying agents with improved survival and prognosis would optimize patient management and inform decision-making for airway management in this vulnerable population. Moreover, delineating which agents exert minimal adverse effects on mortality and prognosis may provide valuable insight for anesthesiologists, intensivists, emergency medicine physicians, and trauma physicians.
- Conditions
- Critically Ill, Intubation Complication, Oxygenation, Airway Management, Propofol, Ketamine
- Being tested
- induction type for intubation in ICU
- Keywords
- intubation, critically ill patients, airway management
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
induction type for intubation in ICUProcedure or surgery
Clinical data documented throughout the course of hospitalization will be retrieved and analyzed.
| Study group | Role | What they receive |
|---|---|---|
| propofol | required induction of the following agent in ICU patient Receives: Procedure: induction type for intubation in ICU | |
| ketamine | required induction of the following agent in ICU patient Receives: Procedure: induction type for intubation in ICU | |
| ethomidate | required induction of the following agent in ICU patient Receives: Procedure: induction type for intubation in ICU | |
| midazolam | required induction of the following agent in ICU patient Receives: Procedure: induction type for intubation in ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome will be all-cause mortality at day 7 following tracheal intubation
mortality at day 7
Measured: day 7
Secondary outcomes (2)
Peri-intubation cardiovascular collapse
occurrence after induction
Measured: perioperatively
Clinical course outcomes
hospital mortality
Measured: days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start18 Apr 2026
- Primary completion1 Jun 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 806 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeliha Alicikus
- Sponsor type
- Other government
- Collaborators
- University of Florida
- Responsible party
- Sponsor-investigator, Zeliha Alicikus, Umraniye Education and Research Hospital
- Investigators
- TOLGA SARAÇOĞLU, Prof,MD, Principal investigator, Florida University Jacksonville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222007
- Sponsor's protocol ID
- Tolga-01
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Induction Agent Choice With Early Mortality and Prognostic Outcomes in Critically Ill Patients: A Large-Scale Retrospective Cohort Analysis
- ClinicalTrials.gov ID
- NCT07222007
- Acronym / sponsor ID
- Tolga-01
- Conditions
- Critically Ill, Intubation Complication, Oxygenation, Airway Management, Propofol, Ketamine
- Keywords
- intubation, critically ill patients, airway management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 806 participants (actual)
- Lead sponsor
- Zeliha AlicikusOther government
- Collaborators
- University of Florida
- Study start
- 18 Apr 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 29 Oct 2025 (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.
The aim of this retrospective cohort study is to compare the safety and efficacy of induction agents for tracheal intubation in critically ill adult patients.
Detailed description
Endotracheal intubation is an accepted procedure to optimize oxygenation and ventilation and reduce the risk of aspiration for critically ill patients, essential for their management and survival across various settings, including prehospital care, emergency departments (EDs), and intensive care units (ICUs). Despite advancements, peri-intubation complications and hemodynamic instability, which are associated with increased mortality rates, remain a concern. These risks are exacerbated by pathophysiological factors in critically ill patients compared to those undergoing intubation in surgical settings .
A recent international, multicentre, prospective cohort (INTUBE) study of 2964 critically ill patients undergoing tracheal intubation in the ICU, emergency department, or inpatient wards in 29 countries across five continents reported that the most frequently used agents for induction were Propofol (41.5%), Midazolam (36.4%), Etomidate (17.8%), and Ketamine (14.2%).
The choice of induction agent for intubation may have the potential to minimise or exacerbate complication and mortality. Although considerable research has been carried out, critical central question concern which induction agent is most effective in minimizing cardiovascular instability during intubation. As Kotani and Risotto declared in their recent systematic review, the available findings are insufficient to support conclusive statements. Further studies are needed to identify the optimal agent and dosage, taking into account patient variability and concurrent therapeutic interventions.
Understanding the impact of induction agent selection in critically ill patients has the potential to guide clinical practice in emergency and intensive care settings. Identifying agents with improved survival and prognosis would optimize patient management and inform decision-making for airway management in this vulnerable population. Moreover, delineating which agents exert minimal adverse effects on mortality and prognosis may provide valuable insight for anesthesiologists, intensivists, emergency medicine physicians, and trauma physicians.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| propofol | – | Procedure: induction type for intubation in ICUrequired induction of the following agent in ICU patient |
| ketamine | – | Procedure: induction type for intubation in ICUrequired induction of the following agent in ICU patient |
| ethomidate | – | Procedure: induction type for intubation in ICUrequired induction of the following agent in ICU patient |
| midazolam | – | Procedure: induction type for intubation in ICUrequired induction of the following agent in ICU patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU admitted, critically ill patients The study population will include critically ill trauma patients aged 18 years and older who were admitted to the surgical intensive care unit
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Admission to the surgical ICU for critical care
- Administration of one of the studied induction agents
- Availability of complete clinical data
Key exclusion criteria (3 listed)
- Age < 18 years
- Absence of documented induction agent administration
- Incomplete or missing medical records
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 |
|---|---|---|
| induction type for intubation in ICUClinical data documented throughout the course of hospitalization will be retrieved and analyzed. | Procedure or surgery | ethomidate, ketamine, midazolam, propofol |
Primary outcome
Primary Outcome will be all-cause mortality at day 7 following tracheal intubation
Time frame: day 7
mortality at day 7
2 secondary outcomes
Peri-intubation cardiovascular collapse
Time frame: perioperatively
Clinical course outcomes
Time frame: days
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 8 Oct 2026.
- Individual participant dataSharing planned: No
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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.
TOLGA SARAÇOĞLU, Prof,MD principal investigator
Florida University Jacksonville
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 Critically Ill and Intubation Complication, run by Zeliha Alicikus at 1 site in United States.
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 4 inclusion and 3 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 8 Oct 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 United States. 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?
Primary Outcome will be all-cause mortality at day 7 following tracheal intubation (time frame: day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.