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Intubation; Difficult or FailedNCT06656546

Comparison of Ultrasound Techniques for Assessment of Endotracheal Tube Placement

A study testing Tracheal Ultrasound, Lung Ultrasound and Diaphragm Ultrasound in people with Intubation; Difficult or Failed, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intubation; Difficult or Failed
What is being tested?
Tracheal Ultrasound, Lung Ultrasound and Diaphragm Ultrasound
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2024to 19 Jun 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Marmara University Pendik Training and Research Hospital

    Istanbul, 34687

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Tracheal Ultrasound, Lung Ultrasound, Diaphragm Ultrasound
Keywords
Ultrasonography, Rapid sequence intubation, End-tidal carbondioxide, Endotracheal intubation, point-of-care ultrasound, transtracheal ultrasound, lung ultrasound, diaphragm ultrasound, emergency department
Medical subject headings
Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tracheal UltrasoundDiagnostic test

    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 UltrasoundDiagnostic test

    Also called Lung Sliding

    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-clavicular 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 UltrasoundDiagnostic test

    Also called Diaphragm Excursion

    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.

Study groups in NCT06656546
Study groupRoleWhat they receive
Tracheal UltrasoundExperimentalThe 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.
Receives: Diagnostic Test: Tracheal Ultrasound
Lung UltrasoundExperimentalThe 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.
Receives: Diagnostic Test: Lung Ultrasound
Diaphragm UltrasoundExperimentalThe 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.
Receives: Diagnostic Test: Diaphragm Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correct Classification of Endotracheal Tube Position

    The primary outcome was correct classification of endotracheal tube position, tracheal or esophageal, by the assigned ultrasound technique. Classification was considered correct when the ultrasound finding agreed with the reference standard assessment performed by the treating physician using quantitative end tidal carbon dioxide monitoring together with bilateral chest auscultation.

    Measured: Immediately after intubation, assessed within the first 5 minutes after the procedure.

Secondary outcomes (2)
  1. Endotracheal Intubation Confirmation Time

    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.

    Measured: Immediately after intubation, assessed within the first 5 minutes after the procedure.

  2. Sonographer Confidence

    After completing the procedure, the sonographer will rate their experience of confirming endotracheal tube position using ultrasound and their confidence in their interpretation on a 5-point Likert scale, ranging from 1 (not at all confident) to 5 (very confident).

    Measured: Immediately after ultrasound, assessed within the first 5 minutes after the procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2024
  2. Study start1 Jun 2024
  3. Primary completion19 Jun 2025
  4. Study completion19 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06656546
Sponsor's protocol ID
09.2024.629
Status last verified
May 2026
First submitted
22 Oct 2024
Last updated
27 May 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kudu E, Korgan MB, Altun M, Yakin F, Karacabey S, Sanri E, Akoglu H, Denizbasi A. Comparison of three point-of-care ultrasound techniques to confirm endotracheal tube placement: A randomized clinical trial. Am J Emerg Med. 2026 Aug;106:55-61. doi: 10.1016/j.ajem.2026.04.039. Epub 2026 Apr 26.

    PubMed 42066651

Questions about this trial

What is this clinical trial studying?

A study testing Tracheal Ultrasound, Lung Ultrasound and Diaphragm Ultrasound in people with Intubation; Difficult or Failed, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correct Classification of Endotracheal Tube Position (time frame: Immediately after intubation, assessed within the first 5 minutes after the procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06656546, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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