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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Leipzig University Medical Center Academic / other |
| Locations | 1 site (Leipzig, Saxony) |
| Status | Recruiting |
| Started | June 27, 2025 |
| Main results expected | August 2027 |
| Study ends | November 2027 |
| Registry record updated | August 26, 2026 |
| Trial ID | NCT06940219 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
- Principal investigator: Anton J Pelka — Interdisciplinary Medical ICU, Leipzig Medical University Center
- Study coordinator: Anton J Pelka
- Email: anton.pelka@medizin.uni-leipzig.de
- Phone: +49 341 97 12700
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.