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

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

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

Study Overview

• Status: Recruiting
• Conditions: Intubation in Intensive Care Units
• Intervention / Treatment: Procedure: Modified Rapid Sequence Induction; Procedure: Delayed Sequence Induction

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anton J Pelka; Phone Number: +49 341 97 12700; Email: anton.pelka@medizin.uni-leipzig.de
• Study Contact Backup: Name: Sirak Petros, Prof. Dr.; Phone Number: +49 341 97 12700; Email: sirak.petros@uniklinik-leipzig.de

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04317
      • Recruiting
      • Interdisciplinary Medical ICU, Leipzig Medical University Center
      • Contact: Anton J Pelka; Phone Number: +49 341 97 12700; Email: anton.pelka@medizin.uni-leipzig.de
      • Principal Investigator: Anton J Pelka
      • Sub-Investigator: Sirak Petros, Prof. Dr. habil.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RSI; Modified Rapid Sequence Induction	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.; Other Names: Rapid Sequence Intubation
Experimental: DSI; Delayed Sequence Induction	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.; Other Names: DSI; Delayed Sequence Intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Collapse	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.	From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic Instability	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.	From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.
Cardiopulmonary Resuscitation	Cardiopulmonary Resuscitation, defined as any start of chest compressions.	From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.
spO2 after completion of preoxygenation	spO2 [%] after completion of preoxygenation	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.
Lowest spO2 during procedure	Lowest spO2 during procedure	From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
Severe desaturation spO2 < 80%	Any spO2 measured below 80% during the intubation procedure.	From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
Dose of Ketamine	Cumulative dose of Ketamine used.	From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
Dose of Midazolam	Cumlative dose of Midazolam.	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 procedure	Endotracheal aspiration during intubation, defined as clinical observation by the intubating physician.	From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
Number of intubation attempts	Cumulative number of intubation attempts. One attempt is defines as every new introduction of the laryngoskope through the open mouth.	From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
New diagnosis of pneumonia	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.	From start of the procedure (= start of preoxygenation) until 48 hours after start of the procedure.
New diagnosis of pneumothorax	New diagnosis of pneumothorax, defined as: - proof of pneumothorax in thoracic imaging (CT, chest xray, thoracic ultrasound)	From start of the procedure (= start of preoxygenation) until 48 hours after start of the procedure.
ICU-Mortality	ICU-Mortality, defined as death during ICU-stay	From start of the procedure (= start of preoxygenation) until discharge from ICU, assessed up to 90 days.
Number of ICU-free days	Number of days, in which the patient was alive outside any ICU.	From start of the procedure (= start of preoxygenation) until 90 days after start of the procedure.
Number of ventilator-free days	Number of days, in which the patient was alive and free of invasive mechanical ventilation.	From start of the procedure (= start of preoxygenation) until 90 days after start of the procedure.

Collaborators and Investigators

• Sponsor: Leipzig University Medical Center
• Investigators: Principal Investigator: Anton J Pelka, Interdisciplinary Medical ICU, Leipzig Medical University Center

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Airway Management; Intubation; Acute respiratory failure; Rapid Sequence Induction; Delayed Sequence Induction; Intubation in intensive care units
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 419/24-ek

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing will be allowed on reasonable request to the principal investigator after publication of the study results.
• IPD Sharing Time Frame: Data will be accessible after publication of the study results up to ten years.
• IPD Sharing Access Criteria: IPD will be accessible after obtaining the approval of the principal investigator on reasonable request. Access will be provided over a secured platform located at a LeipzigUMC server.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No