Critically Ill Adults Requiring Emergency Tracheal Intubation in the Intensive Care UnitPhase 4POETICNCT07847255
Propofol or Esketamine: Tracheal Intubation Comparison
A Phase 4 study testing Esketamine and Propofol in people with Critically Ill Adults Requiring Emergency Tracheal Intubation in the Intensive Care Unit, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The goal of this clinical trial is to compare how esketamine and propofol affect blood pressure in critically ill adults who need a breathing tube in an intensive care unit (ICU). Placing a breathing tube into the windpipe is called tracheal intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Adults Requiring Emergency Tracheal Intubation in the Intensive Care Unit
- What is being tested?
- Esketamine and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2026to 30 Sep 2028
- Phase
- Phase 4
- 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
Who may be able to join
- Age 18 years or older.
- Critically ill patient receiving care in the participating intensive care unit (ICU) and requiring emergency tracheal intubation using a rapid sequence intubation technique, as determined by the treating clinician.
- Written informed consent provided by the participant or a legally authorized representative. Deferred consent is permitted under the protocol when the participant cannot provide consent because of critical illness, a legally authorized representative cannot be reached in time, and delaying intubation could cause irreversible harm. In these circumstances, written informed consent must be obtained as soon as possible and no later than 72 hours after intubation.
Who cannot join
- Emergency tracheal intubation during cardiac arrest.
- Known or suspected elevated intracranial pressure.
- Severe bradycardia, defined as a heart rate below 50 beats per minute.
- Known allergy to esketamine or propofol.
- Pregnancy or breastfeeding.
- Untreated or inadequately treated hyperthyroidism.
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- Severe chronic liver disease, classified as Child-Pugh class C.
- Alcohol or opioid dependence.
- Psychiatric illness or severe cognitive impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Jiancheng Zhang, 8613554105815, zhjcheng1@126.com
About this study
Official title: Esketamine Versus Propofol for Rapid Sequence Intubation in Critically Ill Patients: A Prospective, Randomized, Open-Label, Controlled Trial
The goal of this clinical trial is to compare how esketamine and propofol affect blood pressure in critically ill adults who need a breathing tube in an intensive care unit (ICU). Placing a breathing tube into the windpipe is called tracheal intubation. Medicines are given to make patients unconscious and relax their muscles so the tube can be placed quickly. This procedure is called rapid sequence intubation. Blood pressure can fall during this process.
The main question is whether esketamine leads to a higher minimum blood pressure than propofol during the first 10 minutes after the study medicine is given. Researchers will measure mean arterial pressure, which is the average pressure in the arteries during one heartbeat. The study will also compare the need for medicines to support blood pressure, complications around tube placement, survival, time on a breathing machine, and length of ICU stay.
Read more
The study will enroll 130 adults aged 18 years or older at one hospital in China. Participants will be assigned by chance, like flipping a coin, to receive either esketamine or propofol through a vein before tube placement. Each participant will have an equal chance of receiving either medicine. The treating team will know which medicine is given. Both groups will receive a muscle relaxant and follow the same standard procedures for tube placement and blood pressure support.
The care team will closely monitor blood pressure, heart rate, and blood oxygen levels before and after tube placement. Researchers will record side effects, including high blood pressure, a fast heart rate, and confusion after the procedure. Participants will continue to receive usual ICU care and will be followed until hospital discharge or death, for up to 60 days.
- Being tested
- Esketamine, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Esketamine - Intervention Description Esketamine will be administered as an intravenous bolus at a dose of 0.5-1.0 mg/kg for induction during rapid sequence intubation. The dose will be individualized according to age and hemodynamic status: 0.5 mg/kg for participants aged 65 years or older or with shock, and 1.0 mg/kg for other participants. Participants will also receive rocuronium 0.6 mg/kg intravenously for neuromuscular blockade. Intubation, monitoring, and blood pressure support will follow a standardized ICU protocol.
PropofolDrug
Propofol - Intervention Description Propofol will be administered as an intravenous bolus at a dose of 1.5 mg/kg for induction during rapid sequence intubation. Participants will also receive rocuronium 0.6 mg/kg intravenously for neuromuscular blockade. Intubation, monitoring, and blood pressure support will follow the same standardized ICU protocol used in the esketamine group.
| Study group | Role | What they receive |
|---|---|---|
| Propofol Group | Active comparator | Not described Receives: Drug: Propofol |
| Esketamine Group | Experimental | Not described Receives: Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest Mean Arterial Pressure Within 10 Minutes After Induction
The lowest mean arterial pressure (MAP), measured in mmHg, recorded during the first 10 minutes after administration of the study induction drug. Blood pressure will be monitored using an arterial catheter, and MAP values will be recorded every 1-2 minutes.
Measured: From administration of the study induction drug through 10 minutes after administration.
Secondary outcomes (11)
Average Mean Arterial Pressure During the First Hour After Induction
The arithmetic mean of all recorded mean arterial pressure (MAP) values during the first hour after administration of the study induction drug. MAP will be measured using an arterial catheter and expressed in mmHg.
Measured: From administration of the study induction drug through 60 minutes after administration.
Percentage of Participants With Cardiovascular Collapse
Percentage of participants requiring initiation of a vasopressor at a norepinephrine-equivalent dose greater than 0.1 micrograms/kg/min or an increase in an existing vasopressor dose of more than 0.1 micrograms/kg/min in norepinephrine equivalents during the assessment period.
Measured: From administration of the study induction drug through 2 minutes after tracheal intubation.
Percentage of Participants With Severe Hypotension
Percentage of participants with mean arterial pressure below 65 mmHg lasting at least 5 consecutive minutes during the first hour after administration of the study induction drug. Measurements obtained during cardiac arrest will be excluded from this assessment.
Measured: From administration of the study induction drug through 60 minutes after administration.
Percentage of Participants With Severe Hypoxemia
Percentage of participants with peripheral oxygen saturation (SpO2) below 80% lasting at least 30 consecutive seconds, measured by pulse oximetry.
Measured: From administration of the study induction drug through 60 minutes after administration.
Percentage of Participants With Cardiac Arrest
Percentage of participants experiencing cardiac arrest requiring chest compressions or defibrillation during the first hour after administration of the study induction drug.
Measured: From administration of the study induction drug through 60 minutes after administration.
Time to Successful Tracheal Intubation
Time in seconds from the start of study induction drug administration to confirmation of correct tracheal tube placement by auscultation and detection of exhaled carbon dioxide. The interval will be measured using a stopwatch.
Measured: From the start of study induction drug administration until confirmation of successful tracheal intubation during the intubation procedure.
All-Cause Mortality Within 7 Days
Percentage of participants who die from any cause within 7 days after randomization. Vital status will be determined through medical record review or telephone follow-up.
Measured: From randomization through Day 7.
All-Cause Mortality Within 28 Days
Percentage of participants who die from any cause within 28 days after randomization. Vital status will be determined through medical record review or telephone follow-up.
Measured: From randomization through Day 28.
All-Cause Mortality During Hospitalization
Percentage of participants who die from any cause during the index hospitalization after randomization, within the maximum follow-up period of 60 days.
Measured: From randomization until hospital discharge or death, whichever occurs first, up to 60 days.
Cumulative Vasopressor Dose During the First 24 Hours
Total amount of all vasopressors administered during the first 24 hours after randomization, converted to norepinephrine-equivalent doses and summed for each participant. Cumulative doses will be calculated from medication administration and infusion records.
Measured: From randomization through 24 hours after randomization.
Duration of Invasive Mechanical Ventilation
Time in hours from tracheal intubation to the first successful liberation from invasive mechanical ventilation, determined from medical records.
Measured: From tracheal intubation until first successful liberation from invasive mechanical ventilation, with observation ending at hospital discharge or death and a maximum follow-up of 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start8 Oct 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill Adults Requiring Emergency Tracheal Intubation in the Intensive Care UnitStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiancheng Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847255
- Sponsor's protocol ID
- zjc202611
- Acronym
- POETIC
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esketamine Versus Propofol for Rapid Sequence Intubation in Critically Ill Patients: A Prospective, Randomized, Open-Label, Controlled Trial
- ClinicalTrials.gov ID
- NCT07847255
- Acronym / sponsor ID
- POETIC / zjc202611
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 29 Sep 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.
The goal of this clinical trial is to compare how esketamine and propofol affect blood pressure in critically ill adults who need a breathing tube in an intensive care unit (ICU). Placing a breathing tube into the windpipe is called tracheal intubation. Medicines are given to make patients unconscious and relax their muscles so the tube can be placed quickly. This procedure is called rapid sequence intubation. Blood pressure can fall during this process.
The main question is whether esketamine leads to a higher minimum blood pressure than propofol during the first 10 minutes after the study medicine is given. Researchers will measure mean arterial pressure, which is the average pressure in the arteries during one heartbeat. The study will also compare the need for medicines to support blood pressure, complications around tube placement, survival, time on a breathing machine, and length of ICU stay.
The study will enroll 130 adults aged 18 years or older at one hospital in China. Participants will be assigned by chance, like flipping a coin, to receive either esketamine or propofol through a vein before tube placement. Each participant will have an equal chance of receiving either medicine. The treating team will know which medicine is given. Both groups will receive a muscle relaxant and follow the same standard procedures for tube placement and blood pressure support.
The care team will closely monitor blood pressure, heart rate, and blood oxygen levels before and after tube placement. Researchers will record side effects, including high blood pressure, a fast heart rate, and confusion after the procedure. Participants will continue to receive usual ICU care and will be followed until hospital discharge or death, for up to 60 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol Group | Active comparator | Drug: Propofol |
| Esketamine Group | Experimental | Drug: Esketamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Critically ill patient receiving care in the participating intensive care unit (ICU) and requiring emergency tracheal intubation using a rapid sequence intubation technique, as determined by the treating clinician.
- Written informed consent provided by the participant or a legally authorized representative. Deferred consent is permitted under the protocol when the participant cannot provide consent because of critical illness, a legally authorized representative cannot be reached in time, and delaying intubation could cause irreversible harm. In these circumstances, written informed consent must be obtained as soon as possible and no later than 72 hours after intubation.
Key exclusion criteria (9 listed)
- Emergency tracheal intubation during cardiac arrest.
- Known or suspected elevated intracranial pressure.
- Severe bradycardia, defined as a heart rate below 50 beats per minute.
- Known allergy to esketamine or propofol.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| EsketamineEsketamine - Intervention Description Esketamine will be administered as an intravenous bolus at a dose of 0.5-1.0 mg/kg for induction during rapid sequence intubation. The dose will be individualized according to age and hemodynamic status: 0.5 mg/kg for participants aged 65 years or older or with shock, and 1.0 mg/kg for other participants. Participants will also receive rocuronium 0.6 mg/kg intravenously for neuromuscular blockade. Intubation, monitoring, and blood pressure support will follow a standardized ICU protocol. | Drug | Esketamine Group |
| PropofolPropofol - Intervention Description Propofol will be administered as an intravenous bolus at a dose of 1.5 mg/kg for induction during rapid sequence intubation. Participants will also receive rocuronium 0.6 mg/kg intravenously for neuromuscular blockade. Intubation, monitoring, and blood pressure support will follow the same standardized ICU protocol used in the esketamine group. | Drug | Propofol Group |
Primary outcome
Lowest Mean Arterial Pressure Within 10 Minutes After Induction
Time frame: From administration of the study induction drug through 10 minutes after administration.
The lowest mean arterial pressure (MAP), measured in mmHg, recorded during the first 10 minutes after administration of the study induction drug. Blood pressure will be monitored using an arterial catheter, and MAP values will be recorded every 1-2 minutes.
11 secondary outcomes
Average Mean Arterial Pressure During the First Hour After Induction
Time frame: From administration of the study induction drug through 60 minutes after administration.
Percentage of Participants With Cardiovascular Collapse
Time frame: From administration of the study induction drug through 2 minutes after tracheal intubation.
Percentage of Participants With Severe Hypotension
Time frame: From administration of the study induction drug through 60 minutes after administration.
Percentage of Participants With Severe Hypoxemia
Time frame: From administration of the study induction drug through 60 minutes after administration.
Percentage of Participants With Cardiac Arrest
Time frame: From administration of the study induction drug through 60 minutes after administration.
Time to Successful Tracheal Intubation
Time frame: From the start of study induction drug administration until confirmation of successful tracheal intubation during the intubation procedure.
All-Cause Mortality Within 7 Days
Time frame: From randomization through Day 7.
All-Cause Mortality Within 28 Days
Time frame: From randomization through Day 28.
All-Cause Mortality During Hospitalization
Time frame: From randomization until hospital discharge or death, whichever occurs first, up to 60 days.
Cumulative Vasopressor Dose During the First 24 Hours
Time frame: From randomization through 24 hours after randomization.
Duration of Invasive Mechanical Ventilation
Time frame: From tracheal intubation until first successful liberation from invasive mechanical ventilation, with observation ending at hospital discharge or death and a maximum follow-up of 60 days.
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 29 Sep 2026.
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.
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esketamine and Propofol in people with Critically Ill Adults Requiring Emergency Tracheal Intubation in the Intensive Care Unit, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 29 Sep 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lowest Mean Arterial Pressure Within 10 Minutes After Induction (time frame: From administration of the study induction drug through 10 minutes after administration.). 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 29 Sep 2026.