- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05036460
Real-time Sonography in Detecting Inadvertent Esophageal Intubation Among Difficult Intubation Patients (SDEIDI)
August 30, 2021 updated by: Tian Yuan, MD, Peking Union Medical College Hospital
Real-time Sonography as an Auxiliary Approach to Detect Inadvertent Esophageal Intubation Before Ventilation Among Suspected Difficult Intubation Patients: a Randomized Control Study
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
278
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tian Yuan, MD
- Phone Number: +8618810261573
- Email: counsissis@sina.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ultrasonography + direct visualization
To detect using ultrasonography assisted direct visualization.
|
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.
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.
|
Experimental: Direct visualization
To detect using 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Upon or within three minutes of performing intubation.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The sensitivity.
Time Frame: 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.
|
Upon or within three minutes of performing intubation.
|
The positive likelihood ratio.
Time Frame: 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.
|
Upon or within three minutes of performing intubation.
|
The negative likelihood ratio.
Time Frame: 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.
|
Upon or within three minutes of performing intubation.
|
The diagnostic odds ratio.
Time Frame: 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.
|
Upon or within three minutes of performing intubation.
|
The positive predictive value.
Time Frame: 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.
|
Upon or within three minutes of performing intubation.
|
The negative predictive value
Time Frame: 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.
|
Upon or within three minutes of performing intubation.
|
The detective self-confidence grade
Time Frame: 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".
|
Upon or within three minutes of performing intubation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yuan Tian, MD, Peking Union Medical College Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Ann Emerg Med. 2017 May;69(5):540.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 20, 2021
Primary Completion (Anticipated)
September 20, 2022
Study Completion (Anticipated)
September 20, 2022
Study Registration Dates
First Submitted
August 26, 2021
First Submitted That Met QC Criteria
August 30, 2021
First Posted (Actual)
September 5, 2021
Study Record Updates
Last Update Posted (Actual)
September 5, 2021
Last Update Submitted That Met QC Criteria
August 30, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- PUMCH-ULT&ETT-DI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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