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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKanuni Sultan Suleyman Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older

Presence of spontaneous breathing.

No prediction of a difficult airway prior to intubation.

Requirement for advanced airway management.

Disqualifiers

Aged under 18 years.

Pregnancy.

Refusal to provide informed consent.

Cardiac arrest prior to intubation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Delayed Sequence Intubation

    Procedure/Surgery

    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.

  • Rapid Sequence Intubation

    Procedure/Surgery

    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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Delayed Sequence IntubationExperimental treatment 1 intervention
Group B: Rapid Sequence IntubationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
During and 1 hours after intubation
2

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

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
3

Mean Arterial Blood pH Levels

Evaluation of acid-base status.

Time frame
Hospital admission, At the time of intubation decision, and 15 minutes post-intubation.
4

Mean Partial Pressure of Carbon Dioxide (PaCO2)

Measure of carbon dioxide in arterial blood.

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

Secondary outcomes

1

Number of intubation attempts

From the initiation of intubation until successful intubation is achieved.

Time frame
During the procedure (from the start of the intubation attempt until confirmation of tube placement).
2

Intubation Duration

Time from the laryngoscope blade passing the incisors until successful ETT placement.

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

Other outcomes

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