Comparison of Ultrasound Methods for Assessment of Endotracheal Tube Placement
NCT ID: NCT06656546
Last Updated: 2024-10-24
Study Results
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Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-06-01
2025-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Tracheal Ultrasound
The success of endotracheal intubation (ETI) will be checked by tracheal ultrasonography. The primary outcome will be the placement of the endotracheal tube (ETT) in the trachea or esophagus. The secondary outcome will assess the duration of the ultrasound procedure. The time measurement will begin immediately after the placement of the ETT and will continue until a decision is made, via ultrasound, regarding whether the intubation is tracheal or esophageal.
Tracheal 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.
Lung Ultrasound
The success of ETI will be checked by lung ultrasonography. The primary outcome will be the placement of the ETT in the trachea or esophagus. The secondary outcome will assess endobronchial intubation and the duration of the ultrasound procedure. The time measurement will begin immediately after the placement of the ETT and will continue until a decision is made, via ultrasound, regarding whether the intubation is tracheal or esophageal.
Lung 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.
Diaphragm Ultrasound
The success of ETI will be checked by diaphragm ultrasonography. The primary outcome will be the placement of the ETT in the trachea or esophagus. The secondary outcome will assess endobronchial intubation and the duration of the ultrasound procedure. The time measurement will begin immediately after the placement of the ETT and will continue until a decision is made, via ultrasound, regarding whether the intubation is tracheal or esophageal.
Diaphragm 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.
Interventions
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Tracheal 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.
Lung 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.
Diaphragm 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients aged \>18 years will be included in the study.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Marmara University Pendik Training and Research Hospital
OTHER
Responsible Party
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Emre Kudu
Principal Investigator
Principal Investigators
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Emre Kudu, MD
Role: STUDY_DIRECTOR
Marmara University Pendik Training and Research Hospital
Locations
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Marmara University Pendik Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Acquisto NM, Mosier JM, Bittner EA, Patanwala AE, Hirsch KG, Hargwood P, Oropello JM, Bodkin RP, Groth CM, Kaucher KA, Slampak-Cindric AA, Manno EM, Mayer SA, Peterson LN, Fulmer J, Galton C, Bleck TP, Chase K, Heffner AC, Gunnerson KJ, Boling B, Murray MJ. Society of Critical Care Medicine Clinical Practice Guidelines for Rapid Sequence Intubation in the Critically Ill Adult Patient. Crit Care Med. 2023 Oct 1;51(10):1411-1430. doi: 10.1097/CCM.0000000000006000. Epub 2023 Sep 14.
Drescher MJ, Conard FU, Schamban NE. Identification and description of esophageal intubation using ultrasound. Acad Emerg Med. 2000 Jun;7(6):722-5. doi: 10.1111/j.1553-2712.2000.tb02055.x. No abstract available.
Roy PS, Joshi N, Garg M, Meena R, Bhati S. Comparison of ultrasonography, clinical method and capnography for detecting correct endotracheal tube placement- A prospective, observational study. Indian J Anaesth. 2022 Dec;66(12):826-831. doi: 10.4103/ija.ija_240_22. Epub 2022 Dec 20.
Chou HC, Tseng WP, Wang CH, Ma MH, Wang HP, Huang PC, Sim SS, Liao YC, Chen SY, Hsu CY, Yen ZS, Chang WT, Huang CH, Lien WC, Chen SC. Tracheal rapid ultrasound exam (T.R.U.E.) for confirming endotracheal tube placement during emergency intubation. Resuscitation. 2011 Oct;82(10):1279-84. doi: 10.1016/j.resuscitation.2011.05.016. Epub 2011 Jun 1.
Sethi AK, Salhotra R, Chandra M, Mohta M, Bhatt S, Kayina CA. Confirmation of placement of endotracheal tube - A comparative observational pilot study of three ultrasound methods. J Anaesthesiol Clin Pharmacol. 2019 Jul-Sep;35(3):353-358. doi: 10.4103/joacp.JOACP_317_18.
Werner SL, Smith CE, Goldstein JR, Jones RA, Cydulka RK. Pilot study to evaluate the accuracy of ultrasonography in confirming endotracheal tube placement. Ann Emerg Med. 2007 Jan;49(1):75-80. doi: 10.1016/j.annemergmed.2006.07.004. Epub 2006 Oct 2.
Lin J, Bellinger R, Shedd A, Wolfshohl J, Walker J, Healy J, Taylor J, Chao K, Yen YH, Tzeng CT, Chou EH. Point-of-Care Ultrasound in Airway Evaluation and Management: A Comprehensive Review. Diagnostics (Basel). 2023 Apr 25;13(9):1541. doi: 10.3390/diagnostics13091541.
Other Identifiers
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09.2024.629
Identifier Type: -
Identifier Source: org_study_id
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