Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06940219

Delayed Against Rapid Sequence Induction in Adults With Medical Diseases Undergoing Emergency Endotracheal Intubation.

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Intubation in Intensive Care Units

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Interdisciplinary Medical ICU, Leipzig Medical University Center

Leipzig, Saxony, 04317, Germany

Location status: Recruiting

Location contact

Anton J Pelka

CONTACT

[email protected]

+49 341 97 12700

Anton J Pelka

PRINCIPAL_INVESTIGATOR

Sirak Petros, Prof. Dr. habil.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Delayed Sequence Induction

Procedure

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.

Other names: Delayed Sequence Intubation, DSI

Modified Rapid Sequence Induction

Procedure

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.

Other names: Rapid Sequence Intubation

Primary outcomes

  1. 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.

Secondary outcomes

  1. Hemodynamic Instability

    Time frame: From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.

    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.

  2. Cardiopulmonary Resuscitation

    Time frame: From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.

    Cardiopulmonary Resuscitation, defined as any start of chest compressions.

  3. 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.

    spO2 [%] after completion of preoxygenation

  4. 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.

    Lowest spO2 during procedure

  5. 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.

    Any spO2 measured below 80% during the intubation procedure.

  6. 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.

    Cumulative dose of Ketamine used.

  7. 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.

    Cumlative dose of Midazolam.

  8. 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.

    Endotracheal aspiration during intubation, defined as clinical observation by the intubating physician.

  9. 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.

    Cumulative number of intubation attempts. One attempt is defines as every new introduction of the laryngoskope through the open mouth.

  10. 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 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.

  11. New diagnosis of pneumothorax

    Time frame: From start of the procedure (= start of preoxygenation) until 48 hours after start of the procedure.

    New diagnosis of pneumothorax, defined as:

    • proof of pneumothorax in thoracic imaging (CT, chest xray, thoracic ultrasound)

  12. ICU-Mortality

    Time frame: From start of the procedure (= start of preoxygenation) until discharge from ICU, assessed up to 90 days.

    ICU-Mortality, defined as death during ICU-stay

  13. 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 days, in which the patient was alive outside any ICU.

  14. Number of ventilator-free days

    Time frame: From start of the procedure (= start of preoxygenation) until 90 days after start of the procedure.

    Number of days, in which the patient was alive and free of invasive mechanical ventilation.

Study contacts

Contact information is provided by the study sponsor or research team.

Anton J Pelka

CONTACT

[email protected]

+49 341 97 12700

Sirak Petros, Prof. Dr.

CONTACT

[email protected]

+49 341 97 12700

Sponsors and collaborators

Lead sponsor

Leipzig University Medical Center

Other

Registry information

Official study 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

Acronym: DARSITUBE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2025
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.