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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-KAEK-18 | Other Identifier | İSTANBUL HAYDARPAŞA NUMUNE EĞİTİM VE ARAŞTIRMA HASTANESİ KLİNİK ARAŞTIRMALAR ETİK KURULU |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed Sequence Intubation | Experimental |
| |
| Rapid Sequence Intubation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of intubation attempts | From the initiation of intubation until successful intubation is achieved. | During the procedure (from the start of the intubation attempt until confirmation of tube placement). |
| Intubation Duration |
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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:
Obtaining informed consent from the patient or their legally authorized representative.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Basaksehir Cam and Sakura City Hospital | Recruiting | Istanbul | Istanbul | 34170 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26759664 | Background | 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. | |
| 25447559 | 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. |
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After publication and upon reasonable request
Data will be available beginning 6 months and ending 36 months after article publication.
Requests for data should be directed to the principal investigator. To gain access, data requestors will need to sign a data access agreement.
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| 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 |
|
| 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 |
Time from the laryngoscope blade passing the incisors until successful ETT placement.
| During the procedure (from the start of the intubation attempt until confirmation of tube placement). |
| İstanbul Haseki Training and Research Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
|
| Kanuni Sultan Süleyman Research and Training Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
|
| Şişli Hamidiye Etfal Training and Research Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
|
| 22050948 | 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. |
| 34535237 | 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. |
| 16454773 | 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. |
| ID | Term |
|---|---|
| D000079603 | Rapid Sequence Induction and Intubation |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
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