Intubation; Difficult or Failed
Conditions
Keywords
Ultrasonography, Rapid sequence intubation, End-tidal carbondioxide
Brief summary
This study is a single-center, randomized clinical trial conducted in an emergency department on intubated patients with rapid sequence intubation. Two sonographers will independently verify the accuracy of the intubation site using the assigned intubation method (tracheal, lung-sliding, or diaphragm) according to the randomization sequence. Each sonographer will be blinded to the other verification methods (physical examination, end-tidal carbon dioxide) being used. The study's primary objective is to compare the diagnostic accuracy of different intubation techniques.
Detailed description
In emergency medicine, endotracheal intubation (ETI) is commonly performed for patients who require airway management due to acute respiratory failure, inadequate oxygenation or ventilation, or an inability to protect the airway resulting from altered consciousness. When ETI is performed outside of a cardiac arrest scenario, a series of steps are followed to optimize the procedure. These steps aim to prevent hypoxia, maintain hemodynamic stability, reduce the risk of aspiration, and increase the success rate of ETI. This methodical approach is known as Rapid Sequence Intubation (RSI). RSI involves preparing the necessary and auxiliary equipment, administering premedication, ensuring oxygenation, and applying anesthetic and neuromuscular blocking agents, followed by the placement of the endotracheal tube (ETT). The procedure concludes with confirming the ETT's placement and providing post-intubation care. The primary goal of ETI is to position the ETT through the vocal cords into the trachea, ensuring that both lungs are ventilated effectively. Incorrect or unrecognized endobronchial intubation can result in hypoventilation and collapse of the non-ventilated lung, while the over-ventilated lung may suffer barotrauma or pneumothorax. Unrecognized esophageal intubation, on the other hand, can lead to failure in ventilation, resulting in hypoxia and subsequent complications, including brain damage and other morbidities. Therefore, ensuring the correct placement of the ETT is crucial to avoid serious adverse outcomes. Various methods have been described to confirm correct ETT placement, including direct visualization during intubation, observation of chest wall movements, bilateral auscultation of lung sounds, end-tidal carbon dioxide (EtCO2) monitoring, fiberoptic bronchoscopy, and chest X-ray. Among these, capnography is considered the gold standard. However, in specific clinical situations, EtCO2 monitoring may be unreliable. Patients in cardiac arrest, patients with severe hypotension, pulmonary embolism, or poor pulmonary reserve may present lower than expected EtCO2 values. Similarly, gastric insufflation, using antacids, or consuming carbonated beverages may result in false-positive readings. The American College of Emergency Physicians (ACEP) guidelines recommend the use of additional confirmation methods after ETT placement. Ultrasound (US) has emerged as a relatively new technique for confirming ETI. Its advantages include being non-invasive, portable, rapid, and capable of providing real-time, accurate results. Additionally, the US is unaffected by environmental noise, which can be challenging in noisy environments such as the emergency department. It is also not influenced by changes in pulmonary blood flow. Several ultrasound techniques have been described to confirm ETT placement. The most commonly used methods include direct visualization of the ETT during intubation (tracheal ultrasound), detection of the lung sliding sign via lung ultrasound to indicate lung aeration and bilateral identification of diaphragmatic movement. Tracheal ultrasound can detect esophageal intubation before ventilation begins, preventing unnecessary gastric insufflation and its associated complications. The lung sliding sign and bilateral diaphragmatic movement techniques can help identify endobronchial intubation by visualizing pleural and diaphragmatic movement, respectively, thereby complementing tracheal ultrasound and reducing the risk of missed endobronchial intubation. A comprehensive literature review revealed that no studies have directly compared these three ultrasound methods. Therefore, this study aims to evaluate the effectiveness of these three ultrasound techniques in confirming ETT placement and to compare the time required for each method. A secondary objective is to compare the time spent using ultrasound with that of auscultation and capnography. Additionally, this study will assess the ability of each ultrasound technique to detect tracheal intubation and, if present, accidental esophageal intubation across all patients.
Interventions
DIAGNOSTIC_TESTTracheal Ultrasound
In the clinic, one of the routinely used ultrasound machines, either the HM70 EVO Linear Probe (5-12 MHz) or the eSaote MyLab Seven Linear Probe (3-13 MHz), will be selected based on suitability for the procedure at the time. A linear transducer will be placed perpendicular to the trachea at the level of the cricoid membrane. During ETI, visualization of the ETT moving within the trachea, specifically behind the cricothyroid membrane, indicates successful intubation. In contrast, if the ETT is mistakenly placed in the esophagus, a double-lumen appearance lateral to the trachea, created by the ETT within the esophagus, suggests esophageal intubation.
DIAGNOSTIC_TESTLung Ultrasound
In the clinic, one of the routinely used ultrasound machines, either the HM70 EVO Linear Probe (5-12 MHz) or the eSaote MyLab Seven Linear Probe (3-13 MHz), will be selected based on suitability for the procedure at the time. Following ETI, the presence of lung sliding will be evaluated using ultrasound with the aid of a linear probe.The transducer will be placed bilaterally along the mid-axillary line, between the second and fifth intercostal spaces, in a coronal orientation. After the ETT is placed and ventilation is initiated, the movement of the visceral and parietal pleura will be assessed. The presence of sliding motion between these pleural layers during ventilation indicates successful intubation, whereas the absence of this movement suggests a failed intubation.
DIAGNOSTIC_TESTDiaphragm Ultrasound
In the clinic, one of the routinely used ultrasound machines, either the HM70 EVO Curvilinear Probe (2-8 MHz) or the eSaote MyLab Seven Curvilinear Probe (1-8 MHz), will be selected based on suitability for the procedure at the time. Using a curvilinear transducer, the probe will be placed along the mid-axillary line, approximately at the seventh to ninth intercostal spaces, in a coronal orientation. The movement of the diaphragm during ventilation will be assessed over the spleen and liver. Diaphragmatic motion during ventilation indicates successful ETI, while the absence of bilateral diaphragmatic movement suggests esophageal intubation. If diaphragmatic movement is only observed on one side, it is indicative of endobronchial intubation.
Sponsors
Marmara University Pendik Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Caregiver, Investigator)
Masking description
During the endotracheal intubation procedure, the intubation itself and associated interventions will be performed by the patient's attending physician and healthcare team. The ultrasound operator, who will be blinded to the intubation process and its outcomes, will wear soundproof headphones to ensure no external auditory cues influence their assessment. The ultrasound operator will determine the intubation placement solely based on their ultrasound findings, and only the operator will have access to the ultrasound images. The rest of the team will remain blinded to the ultrasound results. Additionally, a designated individual will record the duration of the procedures for both the intubation and ultrasound teams to ensure accurate time tracking.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients in the emergency department who require endotracheal intubation (ETI) based on the decision of the primary physician and are intubated using the rapid sequence intubation method. * Patients aged \>18 years will be included in the study.
Exclusion criteria
* Pregnant patients. * Patients with a history of neck or chest surgery that may interfere with ultrasound evaluation. * Patients with cervical spine disease or a history of surgery that could affect diaphragmatic movement. * Patients diagnosed conditions such as pneumothorax that could affect lung ultrasound results, or those in whom pneumothorax is detected upon further evaluation, * Patients who, after being enrolled, withdraw consent either personally or through a relative.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endotracheal Intubation Success | Immediately after intubation, assessed within the first 5 minutes after the procedure. | The primary outcome is the success of endotracheal intubation. The decision will be made by the primary physician based on routine clinical practice and current guidelines. Physical examination and end-tidal carbon dioxide monitoring will be used, among other methods, to assist in this decision. The primary physician will determine at the bedside whether the intubation was successful (tracheal intubation) or unsuccessful (esophageal intubation). Neither the ultrasound operator nor anyone else will intervene in the decision-making process. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endotracheal Intubation Confirmation Time | Immediately after intubation, assessed within the first 5 minutes after the procedure. | The duration of each method used to confirm endotracheal intubation (ultrasonography, physical examination, and end-tidal carbon dioxide) will be recorded separately. The timing will start from the placement of the endotracheal tube and connection to the bag-valve mask, and will end once a determination-successful (tracheal intubation) or unsuccessful (esophageal intubation)-is made using the respective method. If the primary physician determines esophageal intubation, the remaining uncompleted methods will be discontinued to avoid disrupting the patient's routine management or causing harm. If the ultrasonography procedure is not completed, it will be considered unsuccessful. The timing will begin after the completion of intubation and connection to the bag-valve mask, and will continue until a decision is made. The total duration will be recorded. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactEmre Kudu, MD
Backup ContactMehmet B Korgan, MD
Outcome results
None listed