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

NCT ID: NCT05036460

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2022-09-20

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Ultrasonography + direct visualization

To detect using ultrasonography assisted direct visualization.

Group Type: ACTIVE_COMPARATOR

Ultrasonography

Intervention Type: 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

Intervention Type: 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.

Direct visualization

To detect using direct visualization.

Group Type: EXPERIMENTAL

Direct visualization

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tian Yuan, MD

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuan Tian, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Central Contacts

Tian Yuan, MD

Role: CONTACT

counsissis@sina.com

+8618810261573

References

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.

Reference Type: BACKGROUND

PMID: 31843325 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25533140 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25537734 (View on PubMed)

Other Identifiers

PUMCH-ULT&ETT-DI

Identifier Type: -

Identifier Source: org_study_id