Delayed versus Rapid Sequence Induction for emergency endotracheal intubation in adults with medical illness
Delayed Against Rapid Sequence Induction in Critically Ill Adults With Medical Diseases Undergoing Emergency Endotracheal Intubation: The DARSITUBE-study, a Monocentric Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leipzig University Medical Center Academic / other |
| Locations | 1 site (Leipzig, Saxony) |
| Trial ID | NCT06940219 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Leipzig, Saxony
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.