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

Not Applicable

• Conditions: Intubation; Difficult or Failed; Intubation Complication; Diagnostic Imaging; Ultrasonography
• Interventions: Procedure: Ultrasonography; Procedure: Direct visualization

• Registration Number: NCT05036460
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-08-30
• Last Update Submitted: 2021-08-30
• Study First Posted: 2021-09-05
• Last Update Posted: 2021-09-05
• Study Start: 2021-09-20
• Primary Completion: 2022-09-20
• Study Completion: 2022-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 278

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasonography + direct visualization	Direct visualization	To detect using ultrasonography assisted direct visualization.
Ultrasonography + direct visualization	Ultrasonography	To detect using ultrasonography assisted direct visualization.
Direct visualization	Direct visualization	To detect using direct visualization.

Primary Outcome Measures

Name	Time	Method
The specificity.	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 Outcome Measures

Name	Time	Method
The positive predictive value.	Upon or within three minutes of performing intubation.	Cases of true positive among detective positive/ cases of detective positive. 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 the group using 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.
The positive likelihood ratio.	Upon or within three minutes of performing intubation.	The positive likelihood ratio is calculated as sensitivity/(1 - specificity). 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 the group using 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.
The diagnostic odds ratio.	Upon or within three minutes of performing intubation.	Positive likelihood ratios/Negative likelihood ratio. 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 the group using 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.
The detective self-confidence grade	Upon or within three minutes of performing intubation.	The detective self-confidence grade will be provided on a four-point scale of 1=" unsure", 2=" less sure", 3=" quite sure", and 4=" sure".
The negative likelihood ratio.	Upon or within three minutes of performing intubation.	The negative likelihood ratio is calculated as (1 - sensitivity)/specificity. 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 the group using 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.
The sensitivity.	Upon or within three minutes of performing intubation.	The detected positive/ true positive. 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 the group using 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.
The negative predictive value	Upon or within three minutes of performing intubation.	Cases of true negative among detective negative/ cases of detective 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 the group using 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.