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Clinical trial Recruiting at 4 sites Interventional Ages 18 and up

Comparing oxygen levels and complications with delayed versus rapid sequence intubation

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

Run by Kanuni Sultan Suleyman Training and Research Hospital · NCT07380763 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment140 (estimated)
SponsorKanuni Sultan Suleyman Training and Research Hospital
Academic / other
Locations4 sites (Istanbul, Istanbul and 3 other locations)
StatusRecruiting
StartedOctober 29, 2025
Main results expectedMay 29, 2026
Study endsJune 29, 2026
Registry record updatedFebruary 2, 2026
Trial IDNCT07380763 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.