Intubation in Intensive Care UnitsDARSITUBENCT06940219
Delayed Against Rapid Sequence Induction in Adults With Medical Diseases Undergoing Emergency Endotracheal Intubation.
A study testing Delayed Sequence Induction and Modified Rapid Sequence Induction in people with Intubation in Intensive Care Units, run by Leipzig University Medical Center at 1 site in Germany.
Trial summary
The goal of this clinical trial is to learn if it is feaseble to conduct a superiority trial comparing two methods for endotracheal intubation in critically ill patients. It will also learn about validity of outcomes regarding endotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation in Intensive Care Units
- What is being tested?
- Delayed Sequence Induction and Modified Rapid Sequence Induction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 27 Jun 2025to Nov 2027
- Phase
- Interventional
- 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 18 years or older in need of emergency endotracheal intubation in the following 60 minutes.
- The planned operateur routinely performs endotracheal intubation in critically ill patients.
Who cannot join
- Endotracheal Intubation performed during cardiopulmonary resuscitation or during "unstable ROSC", defined as Norepinephrine or Epinephrine dose > 0,5 µg/kgKG/min after return of spontaneous circulation.
- Participation in the study is not warranted because of increased risk for the patient or otherwise not justifiable (e.g. active oral bleeding).
- Known allergy against Ketamine, Esketamine, Midazolam or Rocuronium.
- Known contraindication against Ketamine, Esketamine Midazolam or Rocuronium.
- Known or anticipated difficult airway with indication for awake fiberoptic intubation.
- Women with known pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Interdisciplinary Medical ICU, Leipzig Medical University Center
Leipzig, Saxony, 04317
Anton J Pelka, +49 341 97 12700, anton.pelka@medizin.uni-leipzig.de
Anton J Pelka
About this study
Official title: Delayed Against Rapid Sequence Induction in Critically Ill Adults With Medical Diseases Undergoing Emergency Endotracheal Intubation: The DARSITUBE-study, a Monocentric Randomized Controlled Trial
The goal of this clinical trial is to learn if it is feaseble to conduct a superiority trial comparing two methods for endotracheal intubation in critically ill patients. It will also learn about validity of outcomes regarding endotracheal intubation. The main questions it aims to answer are:
- Does performing intubation via Delayed Sequence Induction lower the incidence of severe hemodynamic complications compared to Rapid Sequence Induction?
- How are hemodynamic complications in the severely ill to be measured in order to minimize bias?
Read more
Participants will:
- receive emergency endotracheal intubation via Delayed or Rapid Sequence induction
- receive a phone call 90 days after endotracheal intubation
- outcome parameters outside of follow up phone calls will be routinely collected during the regular ICU-stay, there won't be any additional testing
- Conditions
- Intubation in Intensive Care Units
- Being tested
- Delayed Sequence Induction, Modified Rapid Sequence Induction
- Keywords
- Intubation, Airway Management, Acute respiratory failure, Intensive Care Unit, Rapid Sequence Induction, Delayed Sequence Induction, Intubation in intensive care units
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed Sequence InductionProcedure or surgery
Also called Delayed Sequence Intubation, DSI
Delayed Sequence Induction - fractional dosing of Ketamin and Midazolam until a dissociative status is achieved. Dosing should follow the clinical effect. - start of preoxygenation with Bag-Valve-Mask Device or NIV when dissociative status is achieved for at least 3 minutes. - after completion of preoxygenation: neuromuscular blockade with Rocuronium - after application of Rocuronium: Intubation via standard of care. - should apnoea occur during preoxygenation, the continuation of ventilation via Bag-Valve-Mask or NIV is recommended, but not mandatory.
Modified Rapid Sequence InductionProcedure or surgery
Also called Rapid Sequence Intubation
Modified Rapid Sequence Induction - Preoxygenation FiO2 100% with Bag-Valve-Mask-Device or NIV for at least 3 Minutes. - After completion of Preoxygeniation: application of Midazolam, Ketamin and Rocuronium. - The dosing of medication is determined in advance by the operating physician. - Ventilation via Bag-Valve-Mask-device or NIV after application of rocuronium is allowed. - After application of medication: Intubation via standard of care.
| Study group | Role | What they receive |
|---|---|---|
| RSI | Active comparator | Modified Rapid Sequence Induction Receives: Procedure: Modified Rapid Sequence Induction |
| DSI | Experimental | Delayed Sequence Induction Receives: Procedure: Delayed Sequence Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Collapse
Composite Outcome:
Hemodynamic Instability up to 60 minutes after start of the procedure, defined as:
- any measured RRsyst < 65 mmHg or RRsyst < 90 mmHg for at least 30 minutes and/or
- new need for Norepinephrine or increased dosage of Norepinephrine or need of a volume bolus > 15 ml/kgKG, to sustain a MAP > 65 mmHg/RR syst > 90 mmHg. and/or
Cardiopulmonary Resuscitation up to 60 minutes after start of the procedure.
Measured: From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.
Secondary outcomes (14)
Hemodynamic Instability
Hemodynamic Instability up to 60 minutes after start of the procedure, defined as: - any measured RRsyst < 65 mmHg or RRsyst < 90 mmHg for at least 30 minutes and/or - new need for Norepinephrine or increased dosage of Norepinephrine or need of a volume bolus > 15 ml/kgKG, to sustain a MAP > 65 mmHg/RR syst > 90 mmHg.
Measured: From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.
Cardiopulmonary Resuscitation
Cardiopulmonary Resuscitation, defined as any start of chest compressions.
Measured: From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.
spO2 after completion of preoxygenation
spO2 [%] after completion of preoxygenation
Measured: In both groups: spO2 at the time of application of rocuronium, which will be administered after preoxygenation has been completed and mark the beginning of the intubation procedure.
Lowest spO2 during procedure
Lowest spO2 during procedure
Measured: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
Severe desaturation spO2 < 80%
Any spO2 measured below 80% during the intubation procedure.
Measured: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
Dose of Ketamine
Cumulative dose of Ketamine used.
Measured: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
Dose of Midazolam
Cumlative dose of Midazolam.
Measured: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
Endotracheal aspiration during intubation procedure
Endotracheal aspiration during intubation, defined as clinical observation by the intubating physician.
Measured: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
Number of intubation attempts
Cumulative number of intubation attempts. One attempt is defines as every new introduction of the laryngoskope through the open mouth.
Measured: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
New diagnosis of pneumonia
New diagnosis of pneumonia, defined as clinical interpretation of:
- new infiltration in thoracic imaging (CT, chest xray, thoracic ultrasound)
- proof of pathogen in respiratory material
- worsening of oxygenation.
Measured: From start of the procedure (= start of preoxygenation) until 48 hours after start of the procedure.
New diagnosis of pneumothorax
New diagnosis of pneumothorax, defined as:
- proof of pneumothorax in thoracic imaging (CT, chest xray, thoracic ultrasound)
Measured: From start of the procedure (= start of preoxygenation) until 48 hours after start of the procedure.
ICU-Mortality
ICU-Mortality, defined as death during ICU-stay
Measured: From start of the procedure (= start of preoxygenation) until discharge from ICU, assessed up to 90 days.
Number of ICU-free days
Number of days, in which the patient was alive outside any ICU.
Measured: From start of the procedure (= start of preoxygenation) until 90 days after start of the procedure.
Number of ventilator-free days
Number of days, in which the patient was alive and free of invasive mechanical ventilation.
Measured: From start of the procedure (= start of preoxygenation) until 90 days after start of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start27 Jun 2025
- Primary completionAug 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation in Intensive Care UnitsStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leipzig University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anton Pelka, Leipzig University Medical Center
- Investigators
- Anton J Pelka, Principal investigator, Interdisciplinary Medical ICU, Leipzig Medical University Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940219
- Sponsor's protocol ID
- 419/24-ek
- Acronym
- DARSITUBE
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will be allowed on reasonable request to the principal investigator after publication of the study results.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Against Rapid Sequence Induction in Critically Ill Adults With Medical Diseases Undergoing Emergency Endotracheal Intubation: The DARSITUBE-study, a Monocentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06940219
- Acronym / sponsor ID
- DARSITUBE / 419/24-ek
- Conditions
- Intubation in Intensive Care Units
- Keywords
- Intubation, Airway Management, Acute respiratory failure, Intensive Care Unit, Rapid Sequence Induction, Delayed Sequence Induction, Intubation in intensive care units
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Leipzig University Medical CenterUniversity, hospital or other
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Apr 2025 (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 learn if it is feaseble to conduct a superiority trial comparing two methods for endotracheal intubation in critically ill patients. It will also learn about validity of outcomes regarding endotracheal intubation. The main questions it aims to answer are:
- Does performing intubation via Delayed Sequence Induction lower the incidence of severe hemodynamic complications compared to Rapid Sequence Induction?
- How are hemodynamic complications in the severely ill to be measured in order to minimize bias?
Participants will:
- receive emergency endotracheal intubation via Delayed or Rapid Sequence induction
- receive a phone call 90 days after endotracheal intubation
- outcome parameters outside of follow up phone calls will be routinely collected during the regular ICU-stay, there won't be any additional testing
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSI | Active comparator | Procedure: Modified Rapid Sequence InductionModified Rapid Sequence Induction |
| DSI | Experimental | Procedure: Delayed Sequence InductionDelayed Sequence Induction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients 18 years or older in need of emergency endotracheal intubation in the following 60 minutes.
- The planned operateur routinely performs endotracheal intubation in critically ill patients.
Key exclusion criteria (6 listed)
- Endotracheal Intubation performed during cardiopulmonary resuscitation or during "unstable ROSC", defined as Norepinephrine or Epinephrine dose > 0,5 µg/kgKG/min after return of spontaneous circulation.
- Participation in the study is not warranted because of increased risk for the patient or otherwise not justifiable (e.g. active oral bleeding).
- Known allergy against Ketamine, Esketamine, Midazolam or Rocuronium.
- Known contraindication against Ketamine, Esketamine Midazolam or Rocuronium.
- Known or anticipated difficult airway with indication for awake fiberoptic intubation.
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 |
|---|---|---|
| Delayed Sequence InductionAlso: Delayed Sequence Intubation, DSIDelayed Sequence Induction - fractional dosing of Ketamin and Midazolam until a dissociative status is achieved. Dosing should follow the clinical effect. - start of preoxygenation with Bag-Valve-Mask Device or NIV when dissociative status is achieved for at least 3 minutes. - after completion of preoxygenation: neuromuscular blockade with Rocuronium - after application of Rocuronium: Intubation via standard of care. - should apnoea occur during preoxygenation, the continuation of ventilation via Bag-Valve-Mask or NIV is recommended, but not mandatory. | Procedure or surgery | DSI |
| Modified Rapid Sequence InductionAlso: Rapid Sequence IntubationModified Rapid Sequence Induction - Preoxygenation FiO2 100% with Bag-Valve-Mask-Device or NIV for at least 3 Minutes. - After completion of Preoxygeniation: application of Midazolam, Ketamin and Rocuronium. - The dosing of medication is determined in advance by the operating physician. - Ventilation via Bag-Valve-Mask-device or NIV after application of rocuronium is allowed. - After application of medication: Intubation via standard of care. | Procedure or surgery | RSI |
Primary outcome
Cardiovascular Collapse
Time frame: From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.
Composite Outcome: Hemodynamic Instability up to 60 minutes after start of the procedure, defined as: * any measured RRsyst < 65 mmHg or RRsyst < 90 mmHg for at least 30 minutes and/or * new need for Norepinephrine or increased dosage of Norepinephrine or need of a volume bolus > 15 ml/kgKG, to sustain a MAP > 65 mmHg/RR syst > 90 mmHg. and/or Cardiopulmonary Resuscitation up to 60 minutes after start of the procedure.
14 secondary outcomes
Hemodynamic Instability
Time frame: From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.
Cardiopulmonary Resuscitation
Time frame: From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.
spO2 after completion of preoxygenation
Time frame: In both groups: spO2 at the time of application of rocuronium, which will be administered after preoxygenation has been completed and mark the beginning of the intubation procedure.
Lowest spO2 during procedure
Time frame: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
Severe desaturation spO2 < 80%
Time frame: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
Dose of Ketamine
Time frame: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
Dose of Midazolam
Time frame: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
Endotracheal aspiration during intubation procedure
Time frame: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
Number of intubation attempts
Time frame: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
New diagnosis of pneumonia
Time frame: From start of the procedure (= start of preoxygenation) until 48 hours after start of the procedure.
New diagnosis of pneumothorax
Time frame: From start of the procedure (= start of preoxygenation) until 48 hours after start of the procedure.
ICU-Mortality
Time frame: From start of the procedure (= start of preoxygenation) until discharge from ICU, assessed up to 90 days.
Number of ICU-free days
Time frame: From start of the procedure (= start of preoxygenation) until 90 days after start of the procedure.
Number of ventilator-free days
Time frame: From start of the procedure (= start of preoxygenation) until 90 days after start of the procedure.
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 26 Aug 2026.
- Individual participant dataSharing planned: Yes. Data sharing will be allowed on reasonable request to the principal investigator after publication of the study results.
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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.
Anton J Pelka principal investigator
Interdisciplinary Medical ICU, Leipzig Medical University Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed Sequence Induction and Modified Rapid Sequence Induction in people with Intubation in Intensive Care Units, run by Leipzig University Medical Center at 1 site in Germany.
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 6 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 26 Aug 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 Germany. 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 Anton J Pelka (+49 341 97 12700, anton.pelka@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Collapse (time frame: From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.). 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 26 Aug 2026.