MGPOCUS Assisted Bronchoscopy in Difficult Endotracheal Intubation

Study Overview
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Brief Summary
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Introduction Endoracheal intubation (ETI) is a crucial but risky procedure, especially among patients with suspected difficult endotracheal intubation (DTI). Bronchoscopy, as an improved technique commonly used in DTI, might encounters the difficulties of visualization. The magnetic point-of-care ultrasound (MGPOCUS) not only provide an novel visualization from outside, but also enable the estimation of relative position and trajectory of bronchoscopy. The study aims to evaluate the efficiency of MGPOCUS assisted bronchoscopy in time taken to the first-attempt success, the first-attempt and overall success of ETI, complications and satisfaction of visualization among patients suspected with DTI. Methods and analysis The current study is a randomized, parallel-group, single-blinded, single-center study. Participants (n=350) will be recruited by primary anesthesiologist and randomized to groups of ETI with bronchoscopy or MGPOCUS assisted bronchoscopy. The primary outcome is time taken to the first-attempt success ETI. Secondary outcomes include procedure time, the first-attempt and overall success, complications and satisfaction of visualization. Cox regression with the Bonferroni correction and the linear mixed regression will be used to analysis the outcomes.

Official Title
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Developing a Magnetic-POCUS-assisted Bronchoscopy in Difficult Endotracheal Intubation

Conditions
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Airway Management

Intervention / Treatment
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* Procedure: MGPOCUS-assisted bronchoscope-guided intubation
* Procedure: Bronchoscope-guided intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 85 years old. Requiring ETI. Anticipated DTI meets one or more positive findings in the airway evaluation, including history, examination, and appropriate investigations of anatomy . 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. At risk of pulmonary or cardiovascular complications during intubation with flexible bronchoscope, including severe hypoxemia, severe pulmonary hypertension, unstable or severe obstructive airway disease. At risk of bleeding during bronchoscope, including anticoagulants or coagulopathy, renal insufficiency, and superior vena cava syndrome. High risk of aspiration. Current pregnancy. Patient unable to cooperate (for awake intubation).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MGPOCUS-assisted bronchoscope-guided intubation<br> | Procedure: MGPOCUS-assisted bronchoscope-guided intubation<br>* Application of ultrasound instruments that can detect magnetic signals to determine the position of the magnetised bronchoscopy to guide the direction of its advancement and thus optimise difficult endotracheal intubation.<br>|
| Experimental: Bronchoscope-guided Intubation<br> | Procedure: Bronchoscope-guided intubation<br>* Routine bronchoscope- guided intubation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to success | Time taken in seconds to successful intubation at the first-attempt | At once after performing intubation at the first attempt and confirming successful endotracheal intubation by capnography | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | Accumulation of every attempts (no more than 2) from bronchoscope passage of teeth to tube well placed. | Whiler performing intubation. | 
| The first-attempt success | Intubation at the first attempt is whether successful or failure, confirmed by capnography. | At once after the first-attempt and confirmed by capnography.. | 
| Overall success | Intubation is whether successful or failure within no more than 2 attempts and no more than 600 seconds, confirmed by capnography. | At once after procedure and confirmed by capnography. | 
| Number of attempts | Number of attempts to fulfill intubation | While performing the procedure | 
| Satisfaction with visualizaiton | Satisfaction with visualization estimated by performers. | At once after every attempt before confirmed by capnography | 
| Intubation relative complications | Including desaturation (<90%), obvious trauma ,bloody secretions, post-extuvation hoarseness and sore throat. | At once after performing procedure and after extubation. |