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Clinical Trials/NCT06656546
NCT06656546CompletedNot Applicable

Comparison of Three Point-of-care Ultrasound Techniques to Confirm Endotracheal Tube Placement: a Randomized Clinical Trial

Marmara University Pendik Training and Research Hospital2 sites in 2 countries200 target enrollmentStarted: June 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
200
Locations
2
Primary Endpoint
Endotracheal Intubation Success

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Double (Care Provider, 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 Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

Tracheal Ultrasound

Experimental

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.

Intervention: Tracheal Ultrasound (Diagnostic Test)

Lung Ultrasound

Experimental

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.

Intervention: Lung Ultrasound (Diagnostic Test)

Diaphragm Ultrasound

Experimental

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.

Intervention: Diaphragm Ultrasound (Diagnostic Test)

Outcomes

Primary Outcomes

Endotracheal Intubation Success

Time Frame: 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 Outcomes

  • Endotracheal Intubation Confirmation Time(Immediately after intubation, assessed within the first 5 minutes after the procedure.)

Investigators

Sponsor
Marmara University Pendik Training and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Emre Kudu

Principal Investigator

Marmara University Pendik Training and Research Hospital

Study Sites (2)

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