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

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

Overview

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.

Interventions

• Procedure Delayed Sequence Intubation
  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
• Procedure Rapid Sequence Intubation
  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, endotrach

Primary outcome measures

• Number of Participants with Procedure-Related Adverse Events [Time frame: During and 1 hours after intubation]
• 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]
• Mean Arterial Blood pH Levels [Time frame: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.]
• Mean Partial Pressure of Carbon Dioxide (PaCO2) [Time frame: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.]
• Mean Arterial Bicarbonate (HCO3) Concentration [Time frame: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.]
• Mean Base Excess (BE) Levels [Time frame: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.]
• Mean Arterial Lactate Concentration [Time frame: Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.]
• First Hour Mortality [Time frame: 1 hour later intubation]
• 28th day mortality [Time frame: 28 days after intubation]

Secondary outcome measures (2)

• Number of intubation attempts [Time frame: During the procedure (from the start of the intubation attempt until confirmation of tube placement).]
• Intubation Duration [Time frame: During the procedure (from the start of the intubation attempt until confirmation of tube placement).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 4 centers

• Basaksehir Cam and Sakura City Hospital — Istanbul
• İstanbul Haseki Training and Research Hospital — Istanbul
• Kanuni Sultan Süleyman Research and Training Hospital — Istanbul
• Şişli Hamidiye Etfal Training and Research Hospital — Istanbul

Publications

• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07380763 · 4975 · 2024-KAEK-18

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗