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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MGPOCUS-assisted bronchoscope-guided intubation | Active Comparator |
| |
| Bronchoscope-guided Intubation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGPOCUS-assisted bronchoscope-guided intubation | Procedure | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peing Union Medical College Hospital | Beijing | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37369409 | Derived | Tian Y, Fei Y, Bai B, Cui X, Zhang Y, Wang C, Yu C, Huang Y. Developing a magnetic POCUS-guided bronchoscope for patients with suspected difficult endotracheal intubation in a general tertiary hospital: protocol for a randomised controlled study. BMJ Open. 2023 Jun 27;13(6):e071325. doi: 10.1136/bmjopen-2022-071325. |
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Data is available upon request from the corresponding author after the completion of the study.
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|
| Bronchoscope-guided intubation | Procedure | Routine bronchoscope- guided intubation. |
|
| 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. |