Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07380763

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

Led by Kanuni Sultan Suleyman Training and Research Hospital · Updated on 2026-02-02

140

Participants Needed

4

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Breathing spontaneously
  • No predicted difficult airway prior to intubation
  • Need for advanced airway management
  • Not in cardiac arrest
  • Intubation planned due to non-traumatic causes
  • Planned use of ketamine for sedation and rocuronium for paralysis
  • Intubation indicated for acute respiratory failure, airway protection, shock states, or neuroprotection
  • Informed consent obtained from patient or legal representative
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Pregnant
  • Refusal to provide informed consent
  • Cardiac arrest prior to intubation
  • Predicted difficult airway
  • Intubation due to trauma
  • Missing or incomplete patient data
  • Clinical improvement during DSI preoxygenation leading to canceled intubation
  • Use of sedatives other than ketamine for RSI
  • Intubations by untrained practitioners
  • Duplicate enrollment during study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Basaksehir Cam and Sakura City Hospital

Istanbul, Istanbul, Turkey (Türkiye), 34170

Actively Recruiting

2

İstanbul Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

Actively Recruiting

3

Kanuni Sultan Süleyman Research and Training Hospital

Istanbul, Turkey (Türkiye)

Actively Recruiting

4

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

U

Utku Murat Kalafat, Associate Professor

CONTACT

M

Muhammed Güner, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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