Peri-intubation HypotensionPhase 4NCT07620327
Effect of Push-Dose Adrenaline on Peri-intubation Hypotension During Rapid Sequence Intubation in the Emergency Department
A Phase 4 study testing Adrenaline and 0.9 % sodium chloride in people with Peri-intubation Hypotension, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Rapid sequence intubation is commonly performed in the emergency department to secure the airway of critically ill patients. However, blood pressure may decrease during or shortly after intubation because of the patient's underlying illness, the effects of induction medications, and the transition to positive-pressure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-intubation Hypotension
- What is being tested?
- Adrenaline and 0.9 % sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Dec 2026
- 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
- Adult patients aged 18 years or older
- Patients in the emergency department for whom the treating physician has made a clinical decision to perform rapid sequence intubation
- Patients who are hypotensive, defined as systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg, or who are considered to be at significant risk of hypotension during rapid sequence intubation
- Written informed consent obtained from the patient or from a legally authorized representative when the patient lacks decision-making capacity
Who cannot join
- Pregnancy
- Known allergy to adrenaline
- Known contraindication to adrenaline administration
- Withdrawal of consent by the patient or legally authorized representative after enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emir Ünal, MD contact
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul, Pendik, 34899
Emre Kudu, MD, +90 5067613610, dr.emre.kudu@gmail.com
Emir Ünal, MD, emirunal@gmail.com
About this study
Official title: Effect of Push-Dose Adrenaline on Peri-intubation Cardiovascular and Clinical Outcomes During Rapid Sequence Intubation in the Emergency Department: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
Rapid sequence intubation is commonly performed in the emergency department to secure the airway of critically ill patients. However, blood pressure may decrease during or shortly after intubation because of the patient's underlying illness, the effects of induction medications, and the transition to positive-pressure ventilation. This complication is known as peri-intubation hypotension and is associated with worse clinical outcomes.
This study will evaluate whether a preemptive low dose of intravenous adrenaline, also known as epinephrine, can reduce peri-intubation hypotension in adult emergency department patients undergoing rapid sequence intubation. Participants will be randomly assigned to receive either 10 mcg of intravenous adrenaline or 1 mL of 0.9% sodium chloride placebo immediately before induction. The study will compare hemodynamic changes, vasopressor requirements, safety outcomes, and mortality between the two groups.
Read the detailed description
Rapid sequence intubation is a standard advanced airway procedure used in emergency departments for critically ill patients who require rapid and secure airway control. Although this procedure is clinically necessary, it may be associated with peri-intubation hypotension, commonly defined as systolic blood pressure below 90 mmHg or mean arterial pressure below 65 mmHg during or after the intubation period. This hemodynamic deterioration may result from the patient's underlying critical illness, the cardiovascular effects of induction agents, reduced venous return after initiation of positive-pressure ventilation, or a combination of these factors.
Preventing hypotension during rapid sequence intubation is an important component of peri-intubation resuscitation. Intravenous fluids and vasopressor infusions are frequently used when hypotension develops, but these interventions may not always be fast enough to prevent early hemodynamic collapse. Push-dose vasopressors are used in emergency and critical care practice to provide short-term hemodynamic support. However, prospective randomized evidence regarding the preemptive use of push-dose adrenaline during emergency department rapid sequence intubation remains limited.
This is a single-center, prospective, randomized, double-blind, placebo-controlled trial conducted in the emergency department of Marmara University Pendik Training and Research Hospital. Adult patients undergoing rapid sequence intubation, who are hypotensive or considered to be at significant risk of hypotension, will be enrolled after informed consent is obtained from the patient or legally authorized representative when applicable.
Participants will be randomized in a parallel-group design to receive either 10 mcg intravenous adrenaline or 1 mL of 0.9% sodium chloride placebo immediately before the administration of induction agents. The intervention and placebo syringes will be identical in volume and appearance. Syringes will be prepared according to the randomization list by an independent non-blinded nurse who will not participate in clinical care, outcome assessment, or data collection. Treating physicians, participants, investigators, care providers, and outcome assessors will remain blinded to group allocation.
The decision to perform intubation, selection and dosing of induction and neuromuscular blocking agents, endotracheal tube size, and post-intubation management will be determined by the treating physician according to standard emergency department practice and current clinical guidance. Study procedures will not delay airway management or standard resuscitative care.
Hemodynamic variables, including systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate, will be recorded at baseline and during the first 60 minutes after intubation. The study will evaluate peri-intubation hypotension, changes in mean arterial pressure, post-intubation vasopressor requirements, new ventricular or supraventricular arrhythmias, reactive hypertension, cardiac arrest, and mortality at predefined time points. The planned enrollment is 128 participants.
- Conditions
- Peri-intubation Hypotension
- Being tested
- Adrenaline, 0.9 % sodium chloride
- Keywords
- Push-dose adrenaline, Push-dose epinephrine, Peri-intubation hypotension, Rapid sequence intubation, Emergency department, Endotracheal intubation, Vasopressor, Epinephrine, Critical care
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdrenalineDrug
Also called Epinephrine
Participants receive 10 mcg of intravenous adrenaline, administered as 1 mL of a 10 mcg/mL dilution, immediately before the administration of induction agents for rapid sequence intubation.
0.9 % sodium chlorideDrug
Also called Normal saline, Placebo
Participants receive 1 mL of 0.9% sodium chloride intravenously as placebo immediately before the administration of induction agents for rapid sequence intubation. The placebo syringe is identical in volume and appearance to the adrenaline syringe.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Adult emergency department patients undergoing rapid sequence intubation who receive standard care and a 1 mL intravenous placebo bolus of 0.9% sodium chloride immediately before induction. Receives: Drug: 0.9 % sodium chloride |
| Push dose adrenaline | Active comparator | Adult emergency department patients undergoing rapid sequence intubation who receive standard care and a preemptive 10 mcg intravenous bolus dose of adrenaline immediately before induction. Receives: Drug: Adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-intubation hypotension
Peri-intubation hypotension will be defined as the occurrence of systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg at any time during the first 60 minutes after intubation. The incidence of peri-intubation hypotension will be compared between the adrenaline and placebo groups.
Measured: Within 60 minutes after intubation
Secondary outcomes (4)
Change in mean arterial pressure from baseline
Mean arterial pressure will be recorded at baseline and at 1, 5, 10, 15, 30, 45, and 60 minutes after intubation. Changes from baseline will be compared between the adrenaline and placebo groups.
Measured: Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation
Change in heart rate from baseline
Heart rate will be recorded at baseline and at 1, 5, 10, 15, 30, 45, and 60 minutes after intubation. Changes from baseline will be compared between the adrenaline and placebo groups.
Measured: Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation
Post-intubation vasopressor requirement
The need for continuous vasopressor infusion after intubation will be recorded. Total vasopressor dose administered during the first hour and the first 24 hours after intubation will be compared between the adrenaline and placebo groups.
Measured: 1 hour and 24 hours after intubation
Adverse events
Adverse events including reactive hypertension, cardiac arrest, mortality
Measured: Within 24 hours after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-intubation HypotensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a parallel-group design to receive either 10 mcg intravenous adrenaline or 1 mL of 0.9% sodium chloride placebo immediately before induction for rapid sequence intubation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Kudu, Marmara University
- Investigators
- Emre Kudu, MD, Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620327
- Sponsor's protocol ID
- 09.2026.764
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Push-Dose Adrenaline on Peri-intubation Cardiovascular and Clinical Outcomes During Rapid Sequence Intubation in the Emergency Department: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07620327
- Acronym / sponsor ID
- 09.2026.764
- Conditions
- Peri-intubation Hypotension
- Keywords
- Push-dose adrenaline, Push-dose epinephrine, Peri-intubation hypotension, Rapid sequence intubation, Emergency department, Endotracheal intubation, Vasopressor, Epinephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Jun 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.
Rapid sequence intubation is commonly performed in the emergency department to secure the airway of critically ill patients. However, blood pressure may decrease during or shortly after intubation because of the patient's underlying illness, the effects of induction medications, and the transition to positive-pressure ventilation. This complication is known as peri-intubation hypotension and is associated with worse clinical outcomes.
This study will evaluate whether a preemptive low dose of intravenous adrenaline, also known as epinephrine, can reduce peri-intubation hypotension in adult emergency department patients undergoing rapid sequence intubation. Participants will be randomly assigned to receive either 10 mcg of intravenous adrenaline or 1 mL of 0.9% sodium chloride placebo immediately before induction. The study will compare hemodynamic changes, vasopressor requirements, safety outcomes, and mortality between the two groups.
Detailed description
Rapid sequence intubation is a standard advanced airway procedure used in emergency departments for critically ill patients who require rapid and secure airway control. Although this procedure is clinically necessary, it may be associated with peri-intubation hypotension, commonly defined as systolic blood pressure below 90 mmHg or mean arterial pressure below 65 mmHg during or after the intubation period. This hemodynamic deterioration may result from the patient's underlying critical illness, the cardiovascular effects of induction agents, reduced venous return after initiation of positive-pressure ventilation, or a combination of these factors.
Preventing hypotension during rapid sequence intubation is an important component of peri-intubation resuscitation. Intravenous fluids and vasopressor infusions are frequently used when hypotension develops, but these interventions may not always be fast enough to prevent early hemodynamic collapse. Push-dose vasopressors are used in emergency and critical care practice to provide short-term hemodynamic support. However, prospective randomized evidence regarding the preemptive use of push-dose adrenaline during emergency department rapid sequence intubation remains limited.
This is a single-center, prospective, randomized, double-blind, placebo-controlled trial conducted in the emergency department of Marmara University Pendik Training and Research Hospital. Adult patients undergoing rapid sequence intubation, who are hypotensive or considered to be at significant risk of hypotension, will be enrolled after informed consent is obtained from the patient or legally authorized representative when applicable.
Participants will be randomized in a parallel-group design to receive either 10 mcg intravenous adrenaline or 1 mL of 0.9% sodium chloride placebo immediately before the administration of induction agents. The intervention and placebo syringes will be identical in volume and appearance. Syringes will be prepared according to the randomization list by an independent non-blinded nurse who will not participate in clinical care, outcome assessment, or data collection. Treating physicians, participants, investigators, care providers, and outcome assessors will remain blinded to group allocation.
The decision to perform intubation, selection and dosing of induction and neuromuscular blocking agents, endotracheal tube size, and post-intubation management will be determined by the treating physician according to standard emergency department practice and current clinical guidance. Study procedures will not delay airway management or standard resuscitative care.
Hemodynamic variables, including systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate, will be recorded at baseline and during the first 60 minutes after intubation. The study will evaluate peri-intubation hypotension, changes in mean arterial pressure, post-intubation vasopressor requirements, new ventricular or supraventricular arrhythmias, reactive hypertension, cardiac arrest, and mortality at predefined time points. The planned enrollment is 128 participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a parallel-group design to receive either 10 mcg intravenous adrenaline or 1 mL of 0.9% sodium chloride placebo immediately before induction for rapid sequence intubation.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: 0.9 % sodium chlorideAdult emergency department patients undergoing rapid sequence intubation who receive standard care and a 1 mL intravenous placebo bolus of 0.9% sodium chloride immediately before induction. |
| Push dose adrenaline | Active comparator | Drug: AdrenalineAdult emergency department patients undergoing rapid sequence intubation who receive standard care and a preemptive 10 mcg intravenous bolus dose of adrenaline immediately before induction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or older
- Patients in the emergency department for whom the treating physician has made a clinical decision to perform rapid sequence intubation
- Patients who are hypotensive, defined as systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg, or who are considered to be at significant risk of hypotension during rapid sequence intubation
- Written informed consent obtained from the patient or from a legally authorized representative when the patient lacks decision-making capacity
Key exclusion criteria (4 listed)
- Pregnancy
- Known allergy to adrenaline
- Known contraindication to adrenaline administration
- Withdrawal of consent by the patient or legally authorized representative after enrollment
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 |
|---|---|---|
| AdrenalineAlso: EpinephrineParticipants receive 10 mcg of intravenous adrenaline, administered as 1 mL of a 10 mcg/mL dilution, immediately before the administration of induction agents for rapid sequence intubation. | Drug | Push dose adrenaline |
| 0.9 % sodium chlorideAlso: Normal saline, PlaceboParticipants receive 1 mL of 0.9% sodium chloride intravenously as placebo immediately before the administration of induction agents for rapid sequence intubation. The placebo syringe is identical in volume and appearance to the adrenaline syringe. | Drug | Placebo |
Primary outcome
Peri-intubation hypotension
Time frame: Within 60 minutes after intubation
Peri-intubation hypotension will be defined as the occurrence of systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg at any time during the first 60 minutes after intubation. The incidence of peri-intubation hypotension will be compared between the adrenaline and placebo groups.
4 secondary outcomes
Change in mean arterial pressure from baseline
Time frame: Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation
Change in heart rate from baseline
Time frame: Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation
Post-intubation vasopressor requirement
Time frame: 1 hour and 24 hours after intubation
Adverse events
Time frame: Within 24 hours after intubation
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 10 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Peri-intubation Hypotension
Not yet recruitingObservational study
Taiwan ED Airway Quality Surveillance Registry (TEAR)
Airway Management, Tracheal Intubation
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.
Emir Ünal, MD contact
Emre Kudu, MD study chair
Marmara University
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 Adrenaline and 0.9 % sodium chloride in people with Peri-intubation Hypotension, run by Marmara University Pendik 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 4 inclusion and 4 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 10 Jun 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. Some participants in this study may receive a placebo. 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?
Contact Emre Kudu, MD (+90 5067613610, dr.emre.kudu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-intubation hypotension (time frame: Within 60 minutes after intubation). 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 10 Jun 2026.