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

NCT06940219 | Recruiting

• 1 other identifier: 419/24-ek
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (14)

• Hemodynamic Instability

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

• Cardiopulmonary Resuscitation

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

• 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

  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%

  From start of the procedure (= start of preoxygenation) until confirmation of successful endotracheal intubation via waveform capnography or bronchoscopy, assessed up to 60 minutes.

Study Arms (2)

RSI

ACTIVE COMPARATOR

Modified Rapid Sequence Induction

Procedure: Modified Rapid Sequence Induction

DSI

EXPERIMENTAL

Delayed Sequence Induction

Procedure: Delayed Sequence Induction

Interventions

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.

Also known as: Delayed Sequence Intubation, DSI

DSI

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.

Also known as: Rapid Sequence Intubation

RSI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leipzig University Medical Center: lead

Study Sites (1)

Interdisciplinary Medical ICU, Leipzig Medical University Center

Leipzig, Saxony, 04317, Germany

RECRUITING

MeSH Terms

Interventions

Rapid Sequence Induction and Intubation

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Anton J Pelka

  Interdisciplinary Medical ICU, Leipzig Medical University Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 23, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be accessible after publication of the study results up to ten years.
• Access Criteria: 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.

Locations

DE (1)