Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07380763

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

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

140

Participants Needed

4

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two methods of helping adult patients breathe using a tube placed in the airway during emergency care. The study focuses on adults who are breathing on their own but need intubation for medical reasons not related to injury. It aims to evaluate oxygen levels, vital signs, procedure success, blood gas results, complications, and early survival following the intubation procedures. This large, multicenter randomized trial uses unique methods like measuring end-tidal CO2 for tube placement confirmation and assessing intubation difficulty with a specific classification system. The study compares Delayed Sequence Intubation (DSI) and Rapid Sequence Intubation (RSI). In DSI, patients receive ketamine to achieve sedation while preserving breathing, followed by preoxygenation and paralysis with rocuronium before intubation. In RSI, patients are preoxygenated first, then given ketamine and rocuronium sequentially before intubation. Both use direct laryngoscopy, and ventilator settings are standardized. Physiological data are recorded throughout the procedures by designated physicians. Participants will be monitored for oxygen levels, blood pH, carbon dioxide, bicarbonate, base excess, lactate levels, and survival rates at various times before, during, and after intubation. The number of intubation attempts and procedure duration are also tracked. Data collection occurs from hospital admission through 28 days post-procedure, with close monitoring of complications and vital signs to assess safety and outcomes during and after intubation.

CONDITIONS

Brief 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 without assistance
  • No predicted difficult airway before intubation
  • Need for advanced airway management
  • Not in cardiac arrest
  • Intubation decision due to non-traumatic medical reasons
  • Planned use of ketamine for sedation and rocuronium for paralysis during intubation
  • Intubation decision based on acute respiratory failure, inability to protect airway, shock states, or neuroprotection needs
  • Informed consent obtained from patient or legal representative
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Pregnant
  • Refusal to give informed consent
  • Cardiac arrest before intubation
  • Anticipated difficult airway
  • Intubation required due to trauma
  • Missing or incomplete patient data
  • Clinical improvement during preoxygenation leading to cancellation of intubation in DSI group
  • Use of sedative other than ketamine for RSI protocol
  • Intubations performed by staff not trained in study protocols
  • Duplicate enrollment during study period due to recurrent presentations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single procedure with monitoring during and up to 1 hour after intubation

Participants receive either Delayed Sequence Intubation or Rapid Sequence Intubation protocols involving sedation, preoxygenation, paralysis, and endotracheal intubation while physiological parameters are recorded.

1 procedure visit and monitoring for 1 hour post-intubation

Follow-up

Duration - 28 days after intubation

Participants are monitored for safety outcomes including survival up to 28 days after intubation.

Follow-up assessments up to 28 days post-intubation

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

Loading map...

Research Team

U

Utku Murat Kalafat, Associate Professor

M

Muhammed Güner, Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial