Comparing oxygen levels and complications with delayed versus rapid sequence intubation
Comparison of Peri-intubation Oxygenation Values and Complications in Patients Intubated With the Delayed Sequential Intubation (DSI) Versus Rapid Sequence Intubation (RSI) Protocols
This tests whether delayed sequence intubation or rapid sequence intubation gives better oxygen levels and fewer complications for adults who are breathing on their own but need a breathing tube for non‑traumatic reasons.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kanuni Sultan Suleyman Training and Research Hospital Academic / other |
| Locations | 4 sites (Istanbul, Istanbul and 3 other locations) |
| Trial ID | NCT07380763 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares two airway management approaches—delayed sequence intubation (DSI) and rapid sequence intubation (RSI)—in adult non‑trauma patients who are spontaneously breathing but require endotracheal intubation. Participants planned for intubation with ketamine for sedation and rocuronium for paralysis will undergo one of the two protocols while clinicians record peri‑intubation oxygen saturation, vital signs, number of attempts, procedure time, arterial blood gas results, immediate complications, and early survival. The study is being conducted across multiple tertiary hospitals in Istanbul and excludes patients with predicted difficult airways or cardiac arrest. Because prior reports are mostly small or trauma‑focused observational series, this trial aims to provide broader controlled data in non‑trauma adults.
Who should consider this trial
Good fit: Adults (≥18 years) who are spontaneously breathing, require advanced airway management for non‑traumatic causes, are not in cardiac arrest, have no predicted difficult airway, and are planned to receive ketamine and rocuronium for intubation.
Not a fit: Patients with traumatic injuries, cardiac arrest, predicted difficult airways, pediatric patients, or those requiring different sedative/paralytic regimens are unlikely to benefit from the findings.
Why it matters
Potential benefit: If successful, the results could identify an approach that maintains higher oxygen levels and reduces complications during emergency intubation.
How similar studies have performed: Previous small observational studies and trauma‑focused reports suggest possible advantages of DSI in selected cases, but there is no large multicenter randomized data confirming superiority.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Istanbul, Istanbul and 3 other locations
- Basaksehir Cam and Sakura City Hospital — Istanbul, Istanbul, Turkey (Türkiye) (Recruiting)
- İstanbul Haseki Training and Research Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
- Kanuni Sultan Süleyman Research and Training Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
- Şişli Hamidiye Etfal Training and Research Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Utku Murat Kalafat, Associate Professor
- Email: utkumuratk@yahoo.com
- Phone: +90-507-262-74-04
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.