Clinical trial NCT05036460: Real-time Sonography in Detecting Inadvertent Esophageal Intubation Among Difficult Intubation Patients
Official title: Real-time Sonography as an Auxiliary Approach to Detect Inadvertent Esophageal Intubation Before Ventilation Among Suspected Difficult Intubation Patients: a Randomized Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation; Difficult or Failed
Intubation Complication
Ultrasonography
Diagnostic Imaging
Keywords: Ultrasonography
Intubation
Intratracheal
Esophageal intubation
Difficult intubation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: A single-blind, superiority, randomized controlled study. 224 eligible participants requiring elective orotracheal intubation under general anesthesia with suspected DI will be randomized 1:1 to sonography and direct visualization versus direct visualization alone. The primary objective will be to investigate, in suspected DI patients, if the real-time sonography-assisted with direct visualization results in improved specificity in the detection of inadvertent esophageal intubation before ventilation compared with direct visualization while performing intubation. The secondary objectives will be to compare the sensitivity, positive likelihood ratio (LR+), negative likelihood ratio (LR-), diagnostic odds ratio (DOR), positive predictive value (PPV), negative predictive value (NPV), and detective self-confidence grade using sonography-assisted direct visualization vs direct visualization. Test characteristics will be calculated using standard formulas for a binomial proportion, and the corresponding 95% confidence intervals (CIs), by the Wilson interval method.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: The specificity.
timeFrame: Upon or within three minutes of performing intubation.
Secondary outcomes:
measure: The sensitivity.
timeFrame: Upon or within three minutes of performing intubation.
measure: The positive likelihood ratio.
timeFrame: Upon or within three minutes of performing intubation.
measure: The negative likelihood ratio.
timeFrame: Upon or within three minutes of performing intubation.
measure: The diagnostic odds ratio.
timeFrame: Upon or within three minutes of performing intubation.
measure: The positive predictive value.
timeFrame: Upon or within three minutes of performing intubation.
measure: The negative predictive value
timeFrame: Upon or within three minutes of performing intubation.
measure: The detective self-confidence grade
timeFrame: Upon or within three minutes of performing intubation.
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yuan Tian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.