Comparison of Peri-intubation Oxygenation Values and Complications in Patients Intubated With the Delayed Versus Rapid Sequence Intubation Protocols

Summary

This study compares two different methods of helping patients breathe by placing a tube in their airway (intubation) in an emergency setting. These methods are called Rapid Sequence Intubation (RSI) and Delayed Sequence Intubation (DSI).

The study focuses on adult patients who are still breathing on their own but need a breathing tube for medical reasons not related to an injury (non-trauma).

The main goal of the research is to compare:

* Oxygen levels before and after the procedure.
* The patient's vital signs (such as heart rate and blood pressure).
* The number of attempts needed to successfully place the tube and the time the procedure takes.
* Blood gas results and any complications that occur during or shortly after the procedure.
* Early survival (mortality) rates.

While there are previous studies on trauma patients or small observational reports, there is currently no large-scale, multicenter randomized controlled trial that includes all non-trauma adult patients.

What makes this study unique? Confirmation of Tube Placement: Researchers will use a specific measurement called end-tidal CO2 (etCO2) to confirm the tube is in the right place, a method not used in similar previous studies.

Assessing Difficulty: This study will use the Cormack-Lehane classification system to measure how difficult the intubation was for each patient.

Standardization: For the first time, breathing machine (ventilator) settings will be standardized for all patients in this type of study.

Real-World Practice: By involving all emergency department physicians as practitioners, the study aims to show how these methods work across a wide range of medical teams.

Conditions

• Delayed Sequence Intubation
• Rapid Sequence Induction and Intubation
• Intubation
• Intubation Complications
• Intubation, Endotracheal

Interventions

PROCEDURE

Delayed Sequence Intubation

Patients assigned to the Delayed Sequence Intubation (DSI) protocol will receive an initial dose of 1 mg/kg ketamine. Titrated additional doses of 0.5 mg/kg will be administered until 'adequate sedation/dissociation' is achieved, ensuring the preservation of airway reflexes and spontaneous respiration. Subsequently, 'preoxygenation' will be performed for 3 minutes with 'appropriate positioning,' using a non-rebreather mask or bag-valve-mask combined with a nasal cannula delivering maximum oxygen flow (10-15 L/min). Following the induction of paralysis with an intravenous push of rocuronium (1 mg/kg), endotracheal intubation will be performed using direct laryngoscopy. Throughout the protocol, relevant physiological parameters will be recorded on the study data form by a designated physician.

PROCEDURE

Rapid Sequence Intubation

Patients assigned to the Rapid Sequence Intubation (RSI) protocol will receive 'preoxygenation' for 3 minutes using a non-rebreather mask (NRM) or bag-valve-mask (BVM) combined with a nasal cannula delivering maximum oxygen flow (10-15 L/min), following the necessary preparation period. Subsequently, appropriate sedation and paralysis will be achieved through the sequential administration of intravenous (IV) ketamine (1 mg/kg push) and rocuronium (1 mg/kg IV push). Following induction, endotracheal intubation will be performed via direct laryngoscopy. Throughout the protocol, relevant physiological parameters will be recorded on the study data form by a designated physician

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-29

Primary Completion

2026-05-29

Completion

2026-06-29

Countries

• Turkey (Türkiye)

Study Locations