---
title: Real-time Sonography in Detecting Inadvertent Esophageal Intubation Among Difficult Intubation Patients
nct_id: NCT05036460
overall_status: UNKNOWN
phase: NA
sponsor: Peking Union Medical College Hospital
study_type: INTERVENTIONAL
primary_condition: Intubation; Difficult or Failed
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05036460.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05036460"
ct_last_update_post_date: 2021-09-05
last_seen_at: "2026-05-12T06:09:54.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT05036460](https://clinicaltrials.gov/study/NCT05036460)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 278
- **Lead Sponsor:** Peking Union Medical College Hospital
- **Conditions:** Intubation; Difficult or Failed, Intubation Complication, Ultrasonography, Diagnostic Imaging
- **Start Date:** 2021-09-20
- **Completion Date:** 2022-09-20
- **CT.gov Last Update:** 2021-09-05

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Ultrasonography + direct visualization** (ACTIVE_COMPARATOR) — To detect using ultrasonography assisted direct visualization.
- **Direct visualization** (EXPERIMENTAL) — To detect using 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.
- **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.

## Primary Outcomes

- **The specificity.** _(time frame: Upon or within three minutes of performing intubation.)_ — 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.

## Secondary Outcomes

- **The sensitivity.** _(time frame: Upon or within three minutes of performing intubation.)_
- **The positive likelihood ratio.** _(time frame: Upon or within three minutes of performing intubation.)_
- **The negative likelihood ratio.** _(time frame: Upon or within three minutes of performing intubation.)_
- **The diagnostic odds ratio.** _(time frame: Upon or within three minutes of performing intubation.)_
- **The positive predictive value.** _(time frame: Upon or within three minutes of performing intubation.)_
- **The negative predictive value** _(time frame: Upon or within three minutes of performing intubation.)_
- **The detective self-confidence grade** _(time frame: Upon or within three minutes of performing intubation.)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05036460.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05036460*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*