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

RecruitingNAAges 18 Years - anyAllKanuni Sultan Suleyman Training and Research Hosp…
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In plain words

What the trial is, and whether it could suit you

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-s

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📋 Eligibility rules (as published)
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.
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What it tests

  • Delayed Sequence Intubation
  • Rapid Sequence Intubation
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Where

4 sites
Basaksehir Cam and Sakura City Hospital
Istanbul, Turkey (Türkiye)
İstanbul Haseki Training and Research Hospital
Istanbul, Turkey (Türkiye)
Kanuni Sultan Süleyman Research and Training Hospital
Istanbul, Turkey (Türkiye)
Şişli Hamidiye Etfal Training and Research Hospital
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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