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

Leipzig University Medical Center

Status: Not yet enrolling

Conditions: Intubation in Intensive Care Units

Treatments: Procedure: Delayed Sequence Induction; Procedure: Modified Rapid Sequence Induction

Study type: Interventional

Funder types: Other

Identifiers

NCT06940219

419/24-ek

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

RSI

Active Comparator group

Description:

Modified Rapid Sequence Induction

Treatment:

Procedure: Modified Rapid Sequence Induction

DSI

Experimental group

Description:

Delayed Sequence Induction

Treatment:

Procedure: Delayed Sequence Induction