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

L

Leipzig University Medical Center

Status

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

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

Trial contacts and locations

1

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Central trial contact

Sirak Petros, Prof. Dr.; Anton J Pelka

Data sourced from clinicaltrials.gov

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