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

Leipzig University Medical Center200 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

200

Conditions

Intubation in Intensive Care Units

Interventions

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.

Modified Rapid Sequence InductionPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

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