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

NCT07380763 | Recruiting

• 2 other identifiers: 49752024-KAEK-18
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

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

Keywords

delayed sequence intubation; rapid sequence intubation; RSI; DSI

Outcome Measures

Primary Outcomes (9)

• Number of Participants with Procedure-Related Adverse Events

  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)

  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

  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)

  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

  Measure of bicarbonate in arterial blood.

  Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.

• Mean Base Excess (BE) Levels

  Measure of base excess in arterial blood.

  Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.

• Mean Arterial Lactate Concentration

  Measure of lactate in arterial blood.

  Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.

• First Hour Mortality

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

  1 hour later intubation

• 28th day mortality

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

  28 days after intubation

Secondary Outcomes (2)

• Number of intubation attempts

  During the procedure (from the start of the intubation attempt until confirmation of tube placement).

• Intubation Duration

  During the procedure (from the start of the intubation attempt until confirmation of tube placement).

Study Arms (2)

Delayed Sequence Intubation

EXPERIMENTAL

Procedure: Delayed Sequence Intubation

Rapid Sequence Intubation

ACTIVE COMPARATOR

Procedure: Rapid Sequence Intubation

Interventions

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.

Delayed Sequence Intubation

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

Rapid Sequence Intubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (4)

Basaksehir Cam and Sakura City Hospital

Istanbul, Istanbul, 34170, 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

Related Publications (5)

• Mosier JM, Joshi R, Hypes C, Pacheco G, Valenzuela T, Sakles JC. The Physiologically Difficult Airway. West J Emerg Med. 2015 Dec;16(7):1109-17. doi: 10.5811/westjem.2015.8.27467. Epub 2015 Dec 8.

  PMID: 26759664 BACKGROUND

• Weingart SD, Trueger NS, Wong N, Scofi J, Singh N, Rudolph SS. Delayed sequence intubation: a prospective observational study. Ann Emerg Med. 2015 Apr;65(4):349-55. doi: 10.1016/j.annemergmed.2014.09.025. Epub 2014 Oct 23.

  PMID: 25447559 BACKGROUND

• Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.

  PMID: 22050948 BACKGROUND

• Stanke L, Nakajima S, Zimmerman LH, Collopy K, Fales C, Powers W 4th. Hemodynamic Effects of Ketamine Versus Etomidate for Prehospital Rapid Sequence Intubation. Air Med J. 2021 Sep-Oct;40(5):312-316. doi: 10.1016/j.amj.2021.05.009. Epub 2021 Jul 2.

  PMID: 34535237 BACKGROUND

• Sehdev RS, Symmons DA, Kindl K. Ketamine for rapid sequence induction in patients with head injury in the emergency department. Emerg Med Australas. 2006 Feb;18(1):37-44. doi: 10.1111/j.1742-6723.2006.00802.x.

  PMID: 16454773 BACKGROUND

MeSH Terms

Interventions

Rapid Sequence Induction and Intubation

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques

Central Study Contacts

Utku Murat Kalafat, Associate Professor

CONTACT

+90-507-262-74-04; utkumuratk@yahoo.com

Muhammed Güner, Doctor

CONTACT

+90-534-765-46-93; muhammedgner@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 2, 2026
• Study Start: October 29, 2025
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): June 29, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months and ending 36 months after article publication.
• 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.

Locations

TU (4)