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

Official title

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

Overview

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

Interventions

• 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 vi
• 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.

Primary outcome measures

• Cardiovascular Collapse [Time frame: From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.]

Secondary outcome measures (12)

• Hemodynamic Instability [Time frame: From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.]
• Cardiopulmonary Resuscitation [Time frame: From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.]
• spO2 after completion of preoxygenation [Time frame: 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 [Time frame: 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% [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From start of the procedure (= start of preoxygenation) until 48 hours after start of the procedure.]
• New diagnosis of pneumothorax [Time frame: From start of the procedure (= start of preoxygenation) until 48 hours after start of the procedure.]
• ICU-Mortality [Time frame: From start of the procedure (= start of preoxygenation) until discharge from ICU, assessed up to 90 days.]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Germany · 1 center

• Interdisciplinary Medical ICU, Leipzig Medical University Center — Leipzig

Identifiers

NCT: NCT06940219 · 419/24-ek

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗