Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Delayed versus Rapid Sequence Induction for emergency endotracheal intubation in adults with medical illness

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

Run by Leipzig University Medical Center · NCT06940219 · Data updated 2026-11-12

This trial will test if using Delayed Sequence Induction instead of Rapid Sequence Induction during emergency intubation in critically ill adults lowers the chance of severe blood-pressure or heart-rate complications.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorLeipzig University Medical Center
Academic / other
Locations1 site (Leipzig, Saxony)
StatusRecruiting
StartedJune 27, 2025
Main results expectedAugust 2027
Study endsNovember 2027
Registry record updatedAugust 26, 2026
Trial IDNCT06940219 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (age ≥18) in the ICU who need emergency endotracheal intubation within the next 60 minutes and for whom the planned operator routinely performs intubation are the intended participants.

Probably not a fit

Those undergoing CPR or unstable ROSC, with known allergies or contraindications to the study medications, with anticipated difficult airways requiring awake fiberoptic intubation, or who are pregnant or breastfeeding are not eligible and unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a feasibility interventional comparison of two induction approaches for emergency endotracheal intubation in critically ill adults in an ICU setting. The trial will apply either Delayed Sequence Induction or a Modified Rapid Sequence Induction and collect routinely recorded ICU outcomes plus a single 90‑day phone follow-up. The main goals are to see if Delayed Sequence Induction reduces severe hemodynamic complications and to refine which outcome measures best capture those complications with minimal bias. No additional diagnostic tests are required beyond standard ICU care, and common exclusions include CPR, unstable return of spontaneous circulation, known drug allergies/contraindications, anticipated need for awake fiberoptic intubation, and pregnancy or breastfeeding.

Why it matters

Potential benefit: If successful, the approach could reduce life‑threatening blood pressure and heart‑rate problems during emergency intubation for critically ill patients.

How similar studies have gone: Rapid Sequence Induction is widely used and small studies or observational reports suggest Delayed Sequence Induction may improve oxygenation or hemodynamics, but randomized evidence in critically ill emergency intubation is limited so the approach remains relatively novel in this setting.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Interdisciplinary Medical ICU, Leipzig Medical University Center
    Leipzig, Saxony, Germany
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.