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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSI | Active Comparator | Modified Rapid Sequence Induction |
|
| DSI | Experimental | Delayed Sequence Induction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delayed Sequence Induction | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Collapse | Composite Outcome: Hemodynamic Instability up to 60 minutes after start of the procedure, defined as:
and/or Cardiopulmonary Resuscitation up to 60 minutes after start of the procedure. | From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From start of the procedure (= start of preoxygenation) until 60 minutes after start of the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anton J Pelka | Contact | +49 341 97 12700 | anton.pelka@medizin.uni-leipzig.de | |
| Sirak Petros, Prof. Dr. | Contact | +49 341 97 12700 | sirak.petros@uniklinik-leipzig.de |
| Name | Affiliation | Role |
|---|---|---|
| Anton J Pelka | Interdisciplinary Medical ICU, Leipzig Medical University Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Interdisciplinary Medical ICU, Leipzig Medical University Center | Recruiting | Leipzig | Saxony | 04317 | Germany |
Data sharing will be allowed on reasonable request to the principal investigator after publication of the study results.
Data will be accessible after publication of the study results up to ten years.
IPD will be accessible after obtaining the approval of the principal investigator on reasonable request. Access will be provided over a secured platform located at a LeipzigUMC server.
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|
|
| Modified Rapid Sequence Induction | 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. |
|
|
| Cardiopulmonary Resuscitation | Cardiopulmonary Resuscitation, defined as any start of chest compressions. | 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 | 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 | Lowest spO2 during procedure | 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% | Any spO2 measured below 80% during the intubation procedure. | 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 | Cumulative dose of Ketamine used. | 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 | Cumlative dose of Midazolam. | 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 | Endotracheal aspiration during intubation, defined as clinical observation by the intubating physician. | 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 | Cumulative number of intubation attempts. One attempt is defines as every new introduction of the laryngoskope through the open mouth. | 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 | New diagnosis of pneumonia, defined as clinical interpretation of:
| From start of the procedure (= start of preoxygenation) until 48 hours after start of the procedure. |
| New diagnosis of pneumothorax | New diagnosis of pneumothorax, defined as: - proof of pneumothorax in thoracic imaging (CT, chest xray, thoracic ultrasound) | From start of the procedure (= start of preoxygenation) until 48 hours after start of the procedure. |
| ICU-Mortality | ICU-Mortality, defined as death during ICU-stay | From start of the procedure (= start of preoxygenation) until discharge from ICU, assessed up to 90 days. |
| Number of ICU-free days | Number of days, in which the patient was alive outside any ICU. | From start of the procedure (= start of preoxygenation) until 90 days after start of the procedure. |
| Number of ventilator-free days | Number of days, in which the patient was alive and free of invasive mechanical ventilation. | From start of the procedure (= start of preoxygenation) until 90 days after start of the procedure. |
| ID | Term |
|---|---|
| D000079603 | Rapid Sequence Induction and Intubation |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
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