Trial Outcomes & Findings for Comparison of Ultrasound Techniques for Assessment of Endotracheal Tube Placement (NCT NCT06656546)
NCT ID: NCT06656546
Last Updated: 2026-05-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Immediately after intubation, assessed within the first 5 minutes after the procedure.
Results posted on
2026-05-12
Participant Flow
Participant milestones
| Measure |
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-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 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
67
|
67
|
|
Overall Study
COMPLETED
|
66
|
67
|
67
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tracheal Ultrasound
n=66 Participants
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
n=67 Participants
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-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 Ultrasound
n=67 Participants
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.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Intubation time, median (IQR)
|
31.2 seconds
n=66 Participants
|
29.2 seconds
n=67 Participants
|
33.9 seconds
n=67 Participants
|
31.9 seconds
n=200 Participants
|
|
Indication for intubation
Decreased level of consciousness
|
39 Participants
n=66 Participants
|
38 Participants
n=67 Participants
|
35 Participants
n=67 Participants
|
112 Participants
n=200 Participants
|
|
Indication for intubation
Respiratory failure
|
27 Participants
n=66 Participants
|
29 Participants
n=67 Participants
|
32 Participants
n=67 Participants
|
88 Participants
n=200 Participants
|
|
Age, Continuous
|
75 years
n=66 Participants
|
74 years
n=67 Participants
|
75 years
n=67 Participants
|
75 years
n=200 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=66 Participants
|
28 Participants
n=67 Participants
|
33 Participants
n=67 Participants
|
91 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=66 Participants
|
39 Participants
n=67 Participants
|
34 Participants
n=67 Participants
|
109 Participants
n=200 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Immediately after intubation, assessed within the first 5 minutes after the procedure.Population: All randomized participants were included in the primary outcome analysis. There were no missing data for the primary outcome.
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.
Outcome measures
| Measure |
Tracheal Ultrasound
n=66 Participants
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
n=67 Participants
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-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 Ultrasound
n=67 Participants
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.
|
|---|---|---|---|
|
Correct Classification of Endotracheal Tube Position
|
65 Participants
|
66 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Tracheal Ultrasound
n=66 Participants
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
n=67 Participants
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-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 Ultrasound
n=67 Participants
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.
|
|---|---|---|---|
|
Endotracheal Intubation Confirmation Time
|
4.6 seconds
Interval 3.3 to 6.0
|
9.4 seconds
Interval 7.3 to 12.2
|
13.4 seconds
Interval 11.8 to 15.1
|
SECONDARY outcome
Timeframe: Immediately after ultrasound, assessed within the first 5 minutes after the procedure.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).
Outcome measures
| Measure |
Tracheal Ultrasound
n=66 Participants
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
n=67 Participants
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-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 Ultrasound
n=67 Participants
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.
|
|---|---|---|---|
|
Sonographer Confidence
|
4.68 units on a scale
Interval 4.54 to 4.82
|
4.65 units on a scale
Interval 4.51 to 4.8
|
4.65 units on a scale
Interval 4.52 to 4.79
|
Adverse Events
Tracheal Ultrasound
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lung Ultrasound
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diaphragm Ultrasound
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place