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NCT Number: NCT07380763

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Basaksehir Cam and Sakura City Hospital, Istanbul, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older
  • Presence of spontaneous breathing.
  • No prediction of a difficult airway prior to intubation.
  • Requirement for advanced airway management.
  • Not in cardiac arrest.
  • Decided to intubate due to non-traumatic etiologies.
  • Planned intubation using ketamine for sedation and rocuronium for paralysis.
  • Decision to intubate due to one of the following clinical conditions:
  • Acute Respiratory Failure: Patients with hypoxic or hypercapnic respiratory failure where adequate oxygenation cannot be achieved despite non-invasive ventilation.
  • 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.
  • Shock States: Patients in any state of shock (hypovolemic, distributive, cardiogenic, obstructive) exhibiting severe altered mental status or declining respiratory status.
  • 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).
  • Obtaining informed consent from the patient or their legally authorized representative.

Exclusion criteria

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  • Patients assigned to the DSI protocol but for whom the decision to intubate was rescinded due to clinical improvement during the preoxygenation phase.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

Treatment and study plan

Delayed Sequence Intubation

Procedure

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.

Rapid Sequence Intubation

Procedure

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

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. First Hour Mortality

    Time frame: 1 hour later intubation

    Death from any cause within 60 minutes following the intubation attempt.

  9. 28th day mortality

    Time frame: 28 days after intubation

    All-cause mortality recorded during the first 28 days after enrollment.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammed Güner, Doctor

CONTACT

[email protected]

+90-534-765-46-93

Utku Murat Kalafat, Associate Professor

CONTACT

[email protected]

+90-507-262-74-04

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: DSI vs RSI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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