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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-27

Study Completion Date

2027-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Intubation in Intensive Care Units

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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RSI

Modified Rapid Sequence Induction

Group Type ACTIVE_COMPARATOR

Modified Rapid Sequence Induction

Intervention Type PROCEDURE

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.

DSI

Delayed Sequence Induction

Group Type EXPERIMENTAL

Delayed Sequence Induction

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Delayed Sequence Intubation DSI Rapid Sequence Intubation

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No