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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

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

Treatments: Procedure: Ultrasonography; Procedure: Direct visualization

Study type: Interventional

Funder types: Other

Identifiers

NCT05036460

PUMCH-ULT&ETT-DI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 278 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

278 participants in 2 patient groups

Ultrasonography + direct visualization

Active Comparator group

Description:

To detect using ultrasonography assisted direct visualization.

Treatment:

Procedure: Direct visualization

Procedure: Ultrasonography

Direct visualization

Experimental group

Description:

To detect using direct visualization.

Treatment:

Procedure: Direct visualization