Clinical trial NCT06940219: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intubation in Intensive Care Units
Keywords: Intubation
Airway Management
Acute respiratory failure
Intensive Care Unit
Rapid Sequence Induction
Delayed Sequence Induction
Intubation in intensive care units
Lead sponsor: Leipzig University Medical Center
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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


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.

Primary outcomes:
measure: Cardiovascular Collapse
timeFrame: From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.
Secondary outcomes:
measure: Hemodynamic Instability
timeFrame: From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.
measure: Cardiopulmonary Resuscitation
timeFrame: From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure.
measure: spO2 after completion of preoxygenation
timeFrame: 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.
measure: Lowest spO2 during procedure
timeFrame: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
measure: Severe desaturation spO2 < 80%
timeFrame: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
measure: Dose of Ketamine
timeFrame: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
measure: Dose of Midazolam
timeFrame: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
measure: Endotracheal aspiration during intubation procedure
timeFrame: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
measure: Number of intubation attempts
timeFrame: From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.
measure: New diagnosis of pneumonia
timeFrame: From start of the procedure (= start of preoxygenation) until 48 hours after start of the procedure.
measure: New diagnosis of pneumothorax
timeFrame: From start of the procedure (= start of preoxygenation) until 48 hours after start of the procedure.
measure: ICU-Mortality
timeFrame: From start of the procedure (= start of preoxygenation) until discharge from ICU, assessed up to 90 days.
measure: Number of ICU-free days
timeFrame: From start of the procedure (= start of preoxygenation) until 90 days after start of the procedure.
measure: Number of ventilator-free days
timeFrame: From start of the procedure (= start of preoxygenation) until 90 days after start of the procedure.
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Interdisciplinary Medical ICU, Leipzig Medical University Center
state: Saxony
Study officials:
affiliation: Interdisciplinary Medical ICU, Leipzig Medical University Center
name: Anton J Pelka
role: PRINCIPAL_INVESTIGATOR
References: