Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656546
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
Comparison of Ultrasound Methods for Assessment of Endotracheal Tube Placement
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Three Ultrasound Methods for Assessment of Endotracheal Tube Placement During Intubation A Randomised Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 studys 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 ETTs 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None