Comparison of Ultrasound Methods for Assessment of Endotracheal Tube Placement

NCT06656546 | Recruiting

• 1 other identifier: 09.2024.629
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Difficult or Failed

Keywords

Ultrasonography; Rapid sequence intubation; End-tidal carbondioxide

Outcome Measures

Primary Outcomes (1)

• Endotracheal Intubation Success

  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.

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

Secondary Outcomes (1)

• Endotracheal Intubation Confirmation Time

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

Study Arms (3)

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.

Diagnostic Test: Tracheal Ultrasound

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.

Diagnostic Test: Lung Ultrasound

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.

Diagnostic Test: Diaphragm Ultrasound

Interventions

Tracheal Ultrasound DIAGNOSTIC_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.

Tracheal Ultrasound

Lung Ultrasound DIAGNOSTIC_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. 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.

Also known as: Lung Sliding

Lung Ultrasound

Diaphragm Ultrasound DIAGNOSTIC_TEST

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.

Also known as: Diaphragm Excursion

Diaphragm Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, 34687, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• 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.

  PMID: 37707379 BACKGROUND

• 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.

  PMID: 10905655 BACKGROUND

• 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.

  PMID: 36654895 BACKGROUND

• 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.

  PMID: 21684668 BACKGROUND

• 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.

  PMID: 31543584 BACKGROUND

• 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.

  PMID: 17014927 BACKGROUND

• 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.

  PMID: 37174933 BACKGROUND

Study Officials

• Emre Kudu, MD

  Marmara University Pendik Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Emre Kudu, MD

CONTACT

+905067613610; dr.emre.kudu@gmail.com

Mehmet B Korgan, MD

CONTACT

+905447980601; birkankorgan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 24, 2024
• Study Start: June 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)