Cardiovascular CollapseNCT06750939
The Impact of Propofol and Ketamine on Cardiovascular Collapse During Induction for Intubation
An observational study of Cardiovascular Collapse and Intubation Complication, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study evaluates the impact of propofol and ketamine on the risk of cardiovascular collapse during induction for endotracheal intubation in critically ill patients. Induction agents play a crucial role in managing hemodynamic stability, particularly in this vulnerable population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Collapse, Intubation Complication, Anaesthetic Complication Cardiac
- What is being tested?
- propofol and ketamine
- Type of treatment
- Injection or infusion
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2024to 1 Nov 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients admitted to the intensive care unit (ICU) who undergo endotracheal intubation during their ICU stay will be included.
Who may be able to join
- Patients aged over 18 years
- Patients admitted to the intensive care unit (ICU) who undergo endotracheal intubation during their ICU stay will be included.
Who cannot join
- Patients who did not provide consent to participate in the study
- Patients intubated due to cardiac arrest
- Patients intubated outside the intensive care unit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli City Hospital
Köseköy, Kocaeli, 41060
+90 262 225 27 00 3853 Kocaeli City Hospital, +90-262-225-27-00, omeremgin@yahoo.com
About this study
Official title: The Impact of Propofol and Ketamine on Cardiovascular Collapse During Induction for Endotracheal Intubation in Critically Ill Patients: A Prospective Observational Study
This prospective observational study evaluates the impact of propofol and ketamine on the risk of cardiovascular collapse during induction for endotracheal intubation in critically ill patients. Induction agents play a crucial role in managing hemodynamic stability, particularly in this vulnerable population. Propofol, known for its vasodilatory and myocardial depressant effects, has been associated with significant hypotension during induction. Conversely, ketamine, with its sympathomimetic properties, is often considered a safer alternative for hemodynamic stability.
In addition to comparing the incidence of cardiovascular collapse-defined as severe hypotension or cardiac arrest-this study examines the relationship between these induction agents and shock indices, including systolic shock index, diastolic shock index, age-adjusted shock index, and modified shock index. These parameters will provide a more detailed understanding of the hemodynamic effects of each agent and their clinical implications. The findings aim to guide induction agent selection to optimize outcomes in critically ill patients.
- Keywords
- cardiac arrest, intubation, shock index
- Medical subject headings
- Shock, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolOther
The hemodynamic effects of propofol and ketamine are well-documented in the general patient population, yet the incidence and characteristics of cardiovascular collapse induced by these agents in critically ill patients remain underexplored. Cardiovascular collapse, a severe and potentially life-threatening event, may arise due to the unique physiological stressors present in the critical care setting, including pre-existing hemodynamic instability, comorbidities, and the administration of high-risk pharmacological agents. Despite the theoretical understanding of these drugs' pharmacodynamics, there is limited evidence assessing their differential impact on cardiovascular function in this vulnerable population.
This study aims to contribute novel insights to the literature by exploring the association between these widely used sedative-hypnotic agents and the development of cardiovascular collapse. While propofol is known for its potent vasodilatory and myocardial depressive effects,
ketamineOther
The hemodynamic effects of propofol and ketamine are well-documented in the general patient population, yet the incidence and characteristics of cardiovascular collapse induced by these agents in critically ill patients remain underexplored. Cardiovascular collapse, a severe and potentially life-threatening event, may arise due to the unique physiological stressors present in the critical care setting, including pre-existing hemodynamic instability, comorbidities, and the administration of high-risk pharmacological agents. Despite the theoretical understanding of these drugs' pharmacodynamics, there is limited evidence assessing their differential impact on cardiovascular function in this vulnerable population.
This study aims to contribute novel insights to the literature by exploring the association between these widely used sedative-hypnotic agents and the development of cardiovascular collapse. While propofol is known for its potent vasodilatory and myocardial depressive effects,
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular collapse | "- At least one documented episode of SpO₂ < 80%, ensuring accuracy of measurement.
* At least one episode of systolic arterial blood pressure (SAB) < 65 mmHg.
* SAB < 90 mmHg sustained for a duration of 30 minutes.
* Initiation of norepinephrine therapy.
* Escalation of pre-existing norepinephrine infusion dose.
* Administration of >15 mL/kg crystalloid fluids to achieve SAB > 90 mmHg.
* Occurrence of cardiac arrest." The occurrence of any of the above-mentioned events within the first 30 minutes following the initiation of the intervention will be considered as cardiovascular collapse. Receives: Other: propofol; Other: ketamine | |
| No Cardiovascular collapse | Not described Receives: Other: propofol; Other: ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular collapse
- At least one documented episode of SpO₂ < 80%, ensuring accuracy of measurement.
- At least one episode of systolic arterial blood pressure (SAB) < 65 mmHg.
- SAB < 90 mmHg sustained for a duration of 30 minutes.
- Initiation of norepinephrine therapy.
- Escalation of pre-existing norepinephrine infusion dose.
- Administration of >15 mL/kg crystalloid fluids to achieve SAB > 90 mmHg.
- Occurrence of cardiac arrest.
Measured: The occurrence of any of the above-mentioned events within the first 30 minutes following the initiation of the intervention will be considered as cardiovascular collapse.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start15 Jul 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular CollapseStudies 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
- 128 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750939
- Sponsor's protocol ID
- ksh.Oemgin.001
- Status last verified
- Sep 2025
- First submitted
- 5 Dec 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We regret to inform that the data from this study will not be shared due to constraints related to authorization and time limitations. However, those interested may contact the study's corresponding author to request access to the data.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Propofol and Ketamine on Cardiovascular Collapse During Induction for Endotracheal Intubation in Critically Ill Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06750939
- Acronym / sponsor ID
- ksh.Oemgin.001
- Keywords
- cardiac arrest, intubation, shock index
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 27 Dec 2024 (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 the impact of propofol and ketamine on the risk of cardiovascular collapse during induction for endotracheal intubation in critically ill patients. Induction agents play a crucial role in managing hemodynamic stability, particularly in this vulnerable population. Propofol, known for its vasodilatory and myocardial depressant effects, has been associated with significant hypotension during induction. Conversely, ketamine, with its sympathomimetic properties, is often considered a safer alternative for hemodynamic stability.
In addition to comparing the incidence of cardiovascular collapse-defined as severe hypotension or cardiac arrest-this study examines the relationship between these induction agents and shock indices, including systolic shock index, diastolic shock index, age-adjusted shock index, and modified shock index. These parameters will provide a more detailed understanding of the hemodynamic effects of each agent and their clinical implications. The findings aim to guide induction agent selection to optimize outcomes in critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular collapse | – | Other: propofol, Other: ketamine"- At least one documented episode of SpO₂ < 80%, ensuring accuracy of measurement. * At least one episode of systolic arterial blood pressure (SAB) < 65 mmHg. * SAB < 90 mmHg sustained for a duration of 30 minutes. * Initiation of norepinephrine therapy. * Escalation of pre-existing norepinephrine infusion dose. * Administration of >15 mL/kg crystalloid fluids to achieve SAB > 90 mmHg. * Occurrence of cardiac arrest." The occurrence of any of the above-mentioned events within the first 30 minutes following the initiation of the intervention will be considered as cardiovascular collapse. |
| No Cardiovascular collapse | – | Other: propofol, Other: ketamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the intensive care unit (ICU) who undergo endotracheal intubation during their ICU stay will be included.
Key inclusion criteria (2 listed)
- Patients aged over 18 years
- Patients admitted to the intensive care unit (ICU) who undergo endotracheal intubation during their ICU stay will be included.
Key exclusion criteria (3 listed)
- Patients who did not provide consent to participate in the study
- Patients intubated due to cardiac arrest
- Patients intubated outside the intensive care unit
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 |
|---|---|---|
| propofolThe hemodynamic effects of propofol and ketamine are well-documented in the general patient population, yet the incidence and characteristics of cardiovascular collapse induced by these agents in critically ill patients remain underexplored. Cardiovascular collapse, a severe and potentially life-threatening event, may arise due to the unique physiological stressors present in the critical care setting, including pre-existing hemodynamic instability, comorbidities, and the administration of high-risk pharmacological agents. Despite the theoretical understanding of these drugs' pharmacodynamics, there is limited evidence assessing their differential impact on cardiovascular function in this vulnerable population. This study aims to contribute novel insights to the literature by exploring the association between these widely used sedative-hypnotic agents and the development of cardiovascular collapse. While propofol is known for its potent vasodilatory and myocardial depressive effects, | Other | Cardiovascular collapse, No Cardiovascular collapse |
| ketamineThe hemodynamic effects of propofol and ketamine are well-documented in the general patient population, yet the incidence and characteristics of cardiovascular collapse induced by these agents in critically ill patients remain underexplored. Cardiovascular collapse, a severe and potentially life-threatening event, may arise due to the unique physiological stressors present in the critical care setting, including pre-existing hemodynamic instability, comorbidities, and the administration of high-risk pharmacological agents. Despite the theoretical understanding of these drugs' pharmacodynamics, there is limited evidence assessing their differential impact on cardiovascular function in this vulnerable population. This study aims to contribute novel insights to the literature by exploring the association between these widely used sedative-hypnotic agents and the development of cardiovascular collapse. While propofol is known for its potent vasodilatory and myocardial depressive effects, | Other | Cardiovascular collapse, No Cardiovascular collapse |
Primary outcome
cardiovascular collapse
Time frame: The occurrence of any of the above-mentioned events within the first 30 minutes following the initiation of the intervention will be considered as cardiovascular collapse.
* At least one documented episode of SpO₂ < 80%, ensuring accuracy of measurement. * At least one episode of systolic arterial blood pressure (SAB) < 65 mmHg. * SAB < 90 mmHg sustained for a duration of 30 minutes. * Initiation of norepinephrine therapy. * Escalation of pre-existing norepinephrine infusion dose. * Administration of >15 mL/kg crystalloid fluids to achieve SAB > 90 mmHg. * Occurrence of cardiac arrest.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No. We regret to inform that the data from this study will not be shared due to constraints related to authorization and time limitations. However, those interested may contact the study's corresponding author to request access to the data.
Related trials for Cardiovascular Collapse
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
RecruitingObservational study
Role of End-Tidal CO2 During Passive Leg Raising to Predict Fluid Responsiveness in ICU
Circulatory Failure, Critical Illness
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.
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 Cardiovascular Collapse and Intubation Complication, run by Kocaeli City 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 2 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: looking for participants now, as of the sponsor's last update on 22 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ömer Emgin, MD (+90 262 225 27 00, omermgin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular collapse (time frame: The occurrence of any of the above-mentioned events within the first 30 minutes following the initiation of the intervention will be considered as cardiovascular collapse.). 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 22 Sep 2025.