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

January 24, 2026 updated by: Utku Murat Kalafat, Kanuni Sultan Suleyman Training and Research Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Utku Murat Kalafat, Associate Professor
  • Phone Number: +90-507-262-74-04
  • Email: utkumuratk@yahoo.com

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Istanbul Haseki Training and Research Hospital
        • Contact:
        • Sub-Investigator:
          • Özgür Söğüt, Professor
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Kanuni Sultan Süleyman Research and Training Hospital
        • Contact:
          • Utku Murat Kalafat, Associate Professor
          • Phone Number: +90-507-262-74-04
          • Email: utkumuratk@yahoo.com
        • Contact:
        • Principal Investigator:
          • Utku Murat Kalafat, Associate Professor
        • Sub-Investigator:
          • Muhammed Güner, Doctor
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Sisli Hamidiye Etfal Training and Research Hospital
        • Contact:
        • Sub-Investigator:
          • Ertuğrul Altınbilek, Associate Professor
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34170
        • Recruiting
        • Basaksehir Cam and Sakura City Hospital
        • Contact:
        • Sub-Investigator:
          • Nihat Mujdat Hokenek, Associate Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 years or older
  2. Presence of spontaneous breathing.
  3. No prediction of a difficult airway prior to intubation.
  4. Requirement for advanced airway management.
  5. Not in cardiac arrest.
  6. Decided to intubate due to non-traumatic etiologies.
  7. Planned intubation using ketamine for sedation and rocuronium for paralysis.

  8. Decision to intubate due to one of the following clinical conditions:

    1. Acute Respiratory Failure: Patients with hypoxic or hypercapnic respiratory failure where adequate oxygenation cannot be achieved despite non-invasive ventilation.
    2. Inability to Protect the Airway: Altered level of consciousness or increased risk of pulmonary aspiration due to conditions such as upper gastrointestinal bleeding, ileus, volvulus, gastric outlet obstruction, hypersalivation, or hyperemesis.
    3. Shock States: Patients in any state of shock (hypovolemic, distributive, cardiogenic, obstructive) exhibiting severe altered mental status or declining respiratory status.
    4. Neuroprotection: Need to terminate ongoing seizures resistant to medical therapy (status epilepticus), or situations requiring strict control of arterial carbon dioxide (PaCO₂) levels to manage increased intracranial pressure (ICP) in non-traumatic conditions (such as intracranial hemorrhage or severe encephalopathy).
  9. Obtaining informed consent from the patient or their legally authorized representative.

Exclusion Criteria:

  1. Aged under 18 years.
  2. Pregnancy.
  3. Refusal to provide informed consent.
  4. Cardiac arrest prior to intubation.
  5. Anticipated difficult airway.
  6. Intubation required due to traumatic etiologies.
  7. Missing or incomplete patient data.
  8. Patients assigned to the DSI protocol but for whom the decision to intubate was rescinded due to clinical improvement during the preoxygenation phase.
  9. Use of a sedative agent other than ketamine for the RSI protocol.
  10. Intubations performed by practitioners who have not received study-specific training on DSI and RSI protocols.
  11. Duplicate enrollment due to recurrent presentations during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Delayed Sequence Intubation
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.
Active Comparator: Rapid Sequence Intubation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Procedure-Related Adverse Events
Time Frame: During and 1 hours after intubation
Hypoxia(Spo2<90), hypotension (systolic blood pressure <90mmHg or blood pressure drop >20mmg after intiation of intubation protocol), orogastric intubation, cardiac arrest, orolaryngeal trauma, aspiration of orogastric fluid is accepted as procedure-related adverse events
During and 1 hours after intubation
Mean Peripheral Oxygen Saturation (SpO2)
Time Frame: Hospital admission, Intubation decision, Protocol start (0 min), Minutes 1, 2, 3 of protocol, During blade insertion, 1 minute post-intubation, and 5 minutes post-intubation
Spo2 levels at admission, when intubation decision made, Spo2 level upon commencement of the intubation protocol(0-min); Spo2 level at 1st minute, 2nd minute, 3rd minute of intubation protocol, during blade passes incisor teeth, 1 minutes after intubation, 5 minutes after intubation wil be recorded
Hospital admission, Intubation decision, Protocol start (0 min), Minutes 1, 2, 3 of protocol, During blade insertion, 1 minute post-intubation, and 5 minutes post-intubation
Mean Arterial Blood pH Levels
Time Frame: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Evaluation of acid-base status.
Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Mean Partial Pressure of Carbon Dioxide (PaCO2)
Time Frame: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Measure of carbon dioxide in arterial blood.
Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Mean Arterial Bicarbonate (HCO3) Concentration
Time Frame: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Measure of bicarbonate in arterial blood.
Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Mean Base Excess (BE) Levels
Time Frame: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Measure of base excess in arterial blood.
Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Mean Arterial Lactate Concentration
Time Frame: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
Measure of lactate in arterial blood.
Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
First Hour Mortality
Time Frame: 1 hour later intubation
Death from any cause within 60 minutes following the intubation attempt.
1 hour later intubation
28th day mortality
Time Frame: 28 days after intubation
All-cause mortality recorded during the first 28 days after enrollment.
28 days after intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of intubation attempts
Time Frame: During the procedure (from the start of the intubation attempt until confirmation of tube placement).
From the initiation of intubation until successful intubation is achieved.
During the procedure (from the start of the intubation attempt until confirmation of tube placement).
Intubation Duration
Time Frame: During the procedure (from the start of the intubation attempt until confirmation of tube placement).
Time from the laryngoscope blade passing the incisors until successful ETT placement.
During the procedure (from the start of the intubation attempt until confirmation of tube placement).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2025

Primary Completion (Estimated)

May 29, 2026

Study Completion (Estimated)

June 29, 2026

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 24, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4975
  • 2024-KAEK-18 (Other Identifier: İSTANBUL HAYDARPAŞA NUMUNE EĞİTİM VE ARAŞTIRMA HASTANESİ KLİNİK ARAŞTIRMALAR ETİK KURULU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After publication and upon reasonable request

IPD Sharing Time Frame

Data will be available beginning 6 months and ending 36 months after article publication.

IPD Sharing Access Criteria

Requests for data should be directed to the principal investigator. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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