- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07222007
Induction Agent Choice With Early Mortality and Prognostic Outcomes in Critically Ill Patients
Association of Induction Agent Choice With Early Mortality and Prognostic Outcomes in Critically Ill Patients: A Large-Scale Retrospective Cohort Analysis
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: TOLGA SARAÇOĞLU, Prof,MD
- Phone Number: +1 (904) 524-5932
- Email: kemaltolgasaracoglu@gmail.com
Study Contact Backup
- Name: Tolga Saraçoğlu, Asc Prof,MD
- Phone Number: +1 (904) 524-5932
- Email: kemaltolgasaracoglu@gmail.com
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32209
- Recruiting
- UF Health Jacksonville (Shands Hospital)
-
Contact:
- TOLGA Saraçoğlu, prof,md
- Phone Number: 904-524-5932
- Email: kemaltolgasaracoglu@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years
- Admission to the surgical ICU for critical care
- Administration of one of the studied induction agents
- Availability of complete clinical data
Exclusion Criteria:
- Age < 18 years
- Absence of documented induction agent administration
- Incomplete or missing medical records
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
propofol
required induction of the following agent in ICU patient
|
Clinical data documented throughout the course of hospitalization will be retrieved and analyzed.
|
|
ketamine
required induction of the following agent in ICU patient
|
Clinical data documented throughout the course of hospitalization will be retrieved and analyzed.
|
|
ethomidate
required induction of the following agent in ICU patient
|
Clinical data documented throughout the course of hospitalization will be retrieved and analyzed.
|
|
midazolam
required induction of the following agent in ICU patient
|
Clinical data documented throughout the course of hospitalization will be retrieved and analyzed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary Outcome will be all-cause mortality at day 7 following tracheal intubation
Time Frame: day 7
|
mortality at day 7
|
day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peri-intubation cardiovascular collapse
Time Frame: perioperatively
|
occurrence after induction
|
perioperatively
|
|
Clinical course outcomes
Time Frame: days
|
hospital mortality
|
days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: TOLGA SARAÇOĞLU, Prof,MD, Florida University Jacksonville
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tolga-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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