NCT06940219

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

Delayed Against Rapid Sequence Induction in Critically Ill Adults With Medical Diseases Undergoing Emergency Endotracheal Intubation: The DARSITUBE-study, a Monocentric Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Leipzig University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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

Conditions

• Intubation in Intensive Care Units

Interventions

Type	Name	Description
PROCEDURE	Delayed Sequence Induction	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.
PROCEDURE	Modified Rapid Sequence Induction	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.

Timeline

• Start date: 2025-06-27
• Primary completion: 2027-08-01
• Completion: 2027-11-01
• First posted: 2025-04-23
• Last updated: 2025-07-04

Locations

1 site across 1 country: Germany