Real-time Sonography in Detecting Inadvertent Esophageal Intubation Among Difficult Intubation Patients

NCT05036460 | Unknown

• 1 other identifier: PUMCH-ULT&ETT-DI
• Study Type: interventional
• Target: 278
• Locations: 0 countries
• Sites: N/A

Brief Summary

Early detection of esophageal intubation, one of the most common complications while performing endotracheal intubation (ETI), is crucial to adequate airway management, especially among patients suspected of difficult intubation (DI). Detective approaches with ventilation require time, increase the risk of emesis and aspiration to patients, and increase the risk of particle aerosolization to health providers under the epidemic of aerosol-borne diseases. Our study will determine the effectiveness of real-time sonography assisted to direct visualization to detect esophageal intubation before ventilation among DI patients.

Conditions

Intubation; Difficult or Failed; Intubation Complication; Ultrasonography; Diagnostic Imaging

Keywords

Ultrasonography; Intubation; Intratracheal; Esophageal intubation; Difficult intubation

Outcome Measures

Primary Outcomes (1)

• The specificity.

  The detected negative/ true negative. According to the purpose of the proposed study, we will define esophageal intubation as positive, and endotracheal intubation as negative. In group direct visualization, positive and negative are defined as absent and present visualization of the tracheal tube passing through the glottis, respectively. In group ultrasonography assisted direct visualization, positive is defined as sonography detection of esophageal dilation or "double-tract" sign, and negative is defined as direct visualization of the tracheal tube passing through the glottis. If neither the specific US nor the clear visualization is noted, the intubator and the sonographer will discuss and reach a consistent conclusion in three seconds.

  Upon or within three minutes of performing intubation.

Secondary Outcomes (7)

• The sensitivity.

  Upon or within three minutes of performing intubation.

• The positive likelihood ratio.

  Upon or within three minutes of performing intubation.

• The negative likelihood ratio.

  Upon or within three minutes of performing intubation.

• The diagnostic odds ratio.

  Upon or within three minutes of performing intubation.

• The positive predictive value.

  Upon or within three minutes of performing intubation.

Study Arms (2)

Ultrasonography + direct visualization

ACTIVE COMPARATOR

To detect using ultrasonography assisted direct visualization.

Procedure: Ultrasonography; Procedure: Direct visualization

Direct visualization

EXPERIMENTAL

To detect using direct visualization.

Procedure: Direct visualization

Interventions

Ultrasonography PROCEDURE

The transducer will be placed over the anterior neck just above the suprasternal notch, in the transverse orientation. The position of the transducer could be adjusted to visualize both the esophagus and trachea. It will be considered as esophageal intubation if esophageal dilation or "double-tract" sign are noted.

Ultrasonography + direct visualization

Direct visualization PROCEDURE

While performing the intubation, the intubator will report ETI if visualizing the tracheal tube passing through the glottis. Otherwise, it will be regarded as esophageal intubation.

Direct visualization; Ultrasonography + direct visualization

Eligibility Criteria

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

You may qualify if:

• Aged above 18 years old.
• Requiring elective orotracheal intubation under general anesthesia in the OR.
• Suspected DI according to airway assessments ，and with low risk of difficult ventilation.
• Planning to use a Macintosh laryngoscope blade on the first attempt, whether direct or video laryngoscopy.
• Signed written informed consent.
• Willingness for the primary anesthesia team to participate.

You may not qualify if:

• Anterior neck lesions, masses, lacerations, or subcutaneous emphysema.
• A history of neck operation or tracheotomy.
• Allergies to ultrasound coupling gel.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Related Publications (3)

• Gottlieb M, Holladay D, Burns KM, Nakitende D, Bailitz J. Ultrasound for airway management: An evidence-based review for the emergency clinician. Am J Emerg Med. 2020 May;38(5):1007-1013. doi: 10.1016/j.ajem.2019.12.019. Epub 2019 Dec 11.

  PMID: 31843325 BACKGROUND

• Brown CA 3rd, Bair AE, Pallin DJ, Walls RM; NEAR III Investigators. Techniques, success, and adverse events of emergency department adult intubations. Ann Emerg Med. 2015 Apr;65(4):363-370.e1. doi: 10.1016/j.annemergmed.2014.10.036. Epub 2014 Dec 20.

  PMID: 25533140 BACKGROUND

• Das SK, Choupoo NS, Haldar R, Lahkar A. Transtracheal ultrasound for verification of endotracheal tube placement: a systematic review and meta-analysis. Can J Anaesth. 2015 Apr;62(4):413-23. doi: 10.1007/s12630-014-0301-z. Epub 2014 Dec 24.

  PMID: 25537734 BACKGROUND

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Yuan Tian, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tian Yuan, MD

CONTACT

+8618810261573; counsissis@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 5, 2021
• Study Start: September 20, 2021
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share