NCT05036460

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

Real-time Sonography as an Auxiliary Approach to Detect Inadvertent Esophageal Intubation Before Ventilation Among Suspected Difficult Intubation Patients: a Randomized Control Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 278 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Ultrasonography	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.
PROCEDURE	Direct visualization	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.

Timeline

• Start date: 2021-09-20
• Primary completion: 2022-09-20
• Completion: 2022-09-20
• First posted: 2021-09-05
• Last updated: 2021-09-05