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

Официальное название

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

Обзор

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

Вмешательства

• Процедура 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
• Процедура 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.

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Германия · 1 центр

• Interdisciplinary Medical ICU, Leipzig Medical University Center — Leipzig

Идентификаторы

NCT: NCT06940219 · 419/24-ek

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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