Critical IllnessNCT07722897
Assessment of Hemodynamic Responses at Adequate Depth of Anesthesia Using Bispectral Index During Rapid Sequence Intubation in the Emergency Department
An observational study of Critical Illness, run by Akdeniz University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Rapid sequence intubation (RSI) is the standard approach for emergency airway management in critically ill patients requiring endotracheal intubation. Laryngoscopy and tracheal intubation may provoke significant hemodynamic responses, including increases in heart rate and blood pressure, which may adversely affect… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Bispectral Index (BIS) Monitoring
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 1 May 2028
- How long will I take part?
- 1 Day
- 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: Adult patients (≥18 years) requiring rapid sequence intubation (RSI) in the emergency department for airway management. All eligible patients underwent bispectral index (BIS) monitoring before laryngoscopy, and hemodynamic responses were evaluated after confirmation of adequate depth of anesthesia.
Who may be able to join
- Adults aged 18 years or older. Patients undergoing rapid sequence intubation (RSI) in the emergency department.
- Patients in whom bispectral index (BIS) monitoring can be applied before laryngoscopy.
- Patients achieving an adequate depth of anesthesia (BIS 45-55) before laryngoscopy.
- Written informed consent obtained from the patient or a legally authorized representative, when applicable according to local ethics requirements.
Who cannot join
- Age <18 years. Cardiac arrest before or during induction. Patients requiring immediate ("crash") intubation without sufficient time for BIS monitoring.
- Inability to obtain reliable BIS monitoring (e.g., technical failure or inability to place the sensor).
- Pregnancy. Facial or scalp conditions preventing BIS sensor placement. Prisoners or other vulnerable populations if excluded by the ethics protocol.
- -
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
Akdeniz University Hospital
Antalya, 07059
Erkan Göksu, MD, 05054691764, erkangoksu@akdeniz.edu.tr
About this study
Rapid sequence intubation (RSI) is the standard approach for emergency airway management in critically ill patients requiring endotracheal intubation. Laryngoscopy and tracheal intubation may provoke significant hemodynamic responses, including increases in heart rate and blood pressure, which may adversely affect patients with severe neurological or cardiovascular disease.
Although hemodynamic responses during tracheal intubation have been extensively investigated in the anesthesiology literature, evidence from emergency department settings remains limited. Furthermore, previous studies have rarely confirmed whether an adequate depth of anesthesia had been achieved before laryngoscopy, making interpretation of hemodynamic responses difficult.
The aim of this prospective observational study is to evaluate hemodynamic responses during rapid sequence intubation in adult emergency department patients after confirming adequate depth of anesthesia using bispectral index (BIS) monitoring. Heart rate and blood pressure will be recorded before induction, during intubation, and after successful endotracheal intubation, allowing objective assessment of the hemodynamic response under confirmed adequate anesthetic depth.
Read the detailed description
Rapid sequence intubation (RSI) is the standard approach for emergency airway management in critically ill patients requiring endotracheal intubation. Laryngoscopy and tracheal intubation may provoke significant hemodynamic responses, including increases in heart rate and blood pressure, which may adversely affect patients with severe neurological or cardiovascular disease.
Although hemodynamic responses during tracheal intubation have been extensively investigated in the anesthesiology literature, evidence from emergency department settings remains limited. Furthermore, previous studies have rarely confirmed whether an adequate depth of anesthesia had been achieved before laryngoscopy, making interpretation of hemodynamic responses difficult.
The aim of this prospective observational study is to evaluate hemodynamic responses during rapid sequence intubation in adult emergency department patients after confirming adequate depth of anesthesia using bispectral index (BIS) monitoring. Heart rate and blood pressure will be recorded before induction, during intubation, and after successful endotracheal intubation, allowing objective assessment of the hemodynamic response under confirmed adequate anesthetic depth.
- Conditions
- Critical Illness
- Being tested
- Bispectral Index (BIS) Monitoring
- Keywords
- Rapid Sequence Intubation, Emergency Department, Bispectral Index, Hemodynamic Response
- Medical subject headings
- Critical Illness, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral Index (BIS) MonitoringDevice
Bispectral index monitoring is used to assess the depth of anesthesia before laryngoscopy. Endotracheal intubation is performed after an adequate BIS value has been achieved.
| Study group | Role | What they receive |
|---|---|---|
| Emergency Department Patients Undergoing Rapid Sequence Intubation | Adult patients undergoing rapid sequence intubation in the emergency department. Bispectral index (BIS) monitoring is used to confirm adequate depth of anesthesia before laryngoscopy. Hemodynamic parameters are recorded before, during, and after endotracheal intubation. Receives: Device: Bispectral Index (BIS) Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diastolic Blood Pressure Following Rapid Sequence Intubation
Diastolic Blood pressure (MAP) measured before induction, immediately after endotracheal intubation, and at 5, 10, and 15 minutes after intubation in patients with BIS-confirmed adequate depth of anesthesia.
Measured: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
Change in Systolic Blood Pressure Following Rapid Sequence Intubation
Systolic Blood pressure measured before induction, immediately after endotracheal intubation, and at 5, 10, and 15 minutes after intubation in patients with BIS-confirmed adequate depth of anesthesia.
Measured: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
Change in Heart Rate Following Rapid Sequence Intubation
Heart Rate measured before induction, immediately after endotracheal intubation, and at 5, 10, and 15 minutes after intubation in patients with BIS-confirmed adequate depth of anesthesia.
Measured: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 May 2026
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Akdeniz University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erkan Göksu, Akdeniz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722897
- Sponsor's protocol ID
- AkdenizUH1
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forbes AM, Dally FG. Acute hypertension during induction of anaesthesia and endotracheal intubation in normotensive man. Br J Anaesth. 1970 Jul;42(7):618-24. doi: 10.1093/bja/42.7.618. No abstract available.
PubMed 5453244
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hemodynamic Responses at Adequate Depth of Anesthesia Using Bispectral Index During Rapid Sequence Intubation in the Emergency Department
- ClinicalTrials.gov ID
- NCT07722897
- Acronym / sponsor ID
- AkdenizUH1
- Conditions
- Critical Illness
- Keywords
- Rapid Sequence Intubation, Emergency Department, Bispectral Index, Hemodynamic Response
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Akdeniz University HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 23 Jul 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 (RSI) is the standard approach for emergency airway management in critically ill patients requiring endotracheal intubation. Laryngoscopy and tracheal intubation may provoke significant hemodynamic responses, including increases in heart rate and blood pressure, which may adversely affect patients with severe neurological or cardiovascular disease.
Although hemodynamic responses during tracheal intubation have been extensively investigated in the anesthesiology literature, evidence from emergency department settings remains limited. Furthermore, previous studies have rarely confirmed whether an adequate depth of anesthesia had been achieved before laryngoscopy, making interpretation of hemodynamic responses difficult.
The aim of this prospective observational study is to evaluate hemodynamic responses during rapid sequence intubation in adult emergency department patients after confirming adequate depth of anesthesia using bispectral index (BIS) monitoring. Heart rate and blood pressure will be recorded before induction, during intubation, and after successful endotracheal intubation, allowing objective assessment of the hemodynamic response under confirmed adequate anesthetic depth.
Detailed description
Rapid sequence intubation (RSI) is the standard approach for emergency airway management in critically ill patients requiring endotracheal intubation. Laryngoscopy and tracheal intubation may provoke significant hemodynamic responses, including increases in heart rate and blood pressure, which may adversely affect patients with severe neurological or cardiovascular disease.
Although hemodynamic responses during tracheal intubation have been extensively investigated in the anesthesiology literature, evidence from emergency department settings remains limited. Furthermore, previous studies have rarely confirmed whether an adequate depth of anesthesia had been achieved before laryngoscopy, making interpretation of hemodynamic responses difficult.
The aim of this prospective observational study is to evaluate hemodynamic responses during rapid sequence intubation in adult emergency department patients after confirming adequate depth of anesthesia using bispectral index (BIS) monitoring. Heart rate and blood pressure will be recorded before induction, during intubation, and after successful endotracheal intubation, allowing objective assessment of the hemodynamic response under confirmed adequate anesthetic depth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency Department Patients Undergoing Rapid Sequence Intubation | – | Device: Bispectral Index (BIS) MonitoringAdult patients undergoing rapid sequence intubation in the emergency department. Bispectral index (BIS) monitoring is used to confirm adequate depth of anesthesia before laryngoscopy. Hemodynamic parameters are recorded before, during, and after endotracheal intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) requiring rapid sequence intubation (RSI) in the emergency department for airway management. All eligible patients underwent bispectral index (BIS) monitoring before laryngoscopy, and hemodynamic responses were evaluated after confirmation of adequate depth of anesthesia.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older. Patients undergoing rapid sequence intubation (RSI) in the emergency department.
- Patients in whom bispectral index (BIS) monitoring can be applied before laryngoscopy.
- Patients achieving an adequate depth of anesthesia (BIS 45-55) before laryngoscopy.
- Written informed consent obtained from the patient or a legally authorized representative, when applicable according to local ethics requirements.
Key exclusion criteria (4 listed)
- Age <18 years. Cardiac arrest before or during induction. Patients requiring immediate ("crash") intubation without sufficient time for BIS monitoring.
- Inability to obtain reliable BIS monitoring (e.g., technical failure or inability to place the sensor).
- Pregnancy. Facial or scalp conditions preventing BIS sensor placement. Prisoners or other vulnerable populations if excluded by the ethics protocol.
- -
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 |
|---|---|---|
| Bispectral Index (BIS) MonitoringBispectral index monitoring is used to assess the depth of anesthesia before laryngoscopy. Endotracheal intubation is performed after an adequate BIS value has been achieved. | Device | Emergency Department Patients Undergoing Rapid Sequence Intubation |
Primary outcome
Change in Diastolic Blood Pressure Following Rapid Sequence Intubation
Time frame: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
Diastolic Blood pressure (MAP) measured before induction, immediately after endotracheal intubation, and at 5, 10, and 15 minutes after intubation in patients with BIS-confirmed adequate depth of anesthesia.
Change in Systolic Blood Pressure Following Rapid Sequence Intubation
Time frame: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
Systolic Blood pressure measured before induction, immediately after endotracheal intubation, and at 5, 10, and 15 minutes after intubation in patients with BIS-confirmed adequate depth of anesthesia.
Change in Heart Rate Following Rapid Sequence Intubation
Time frame: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation
Heart Rate measured before induction, immediately after endotracheal intubation, and at 5, 10, and 15 minutes after intubation in patients with BIS-confirmed adequate depth of anesthesia.
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 23 Jul 2026.
- Background: PubMed 5453244Forbes AM, Dally FG. Acute hypertension during induction of anaesthesia and endotracheal intubation in normotensive man. Br J Anaesth. 1970 Jul;42(7):618-24. doi: 10.1093/bja/42.7.618. No abstract available.
- 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.
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 Critical Illness, run by Akdeniz University 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: looking for participants now, as of the sponsor's last update on 23 Jul 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. 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 Erkan Göksu, MD (+905054691764, erkangoksu@akdeniz.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diastolic Blood Pressure Following Rapid Sequence Intubation (time frame: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07722897, which also lists 1 linked publication.
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 23 Jul 2026.