Airway Management
Conditions
Brief summary
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.
Interventions
PROCEDUREMGPOCUS-assisted bronchoscope-guided intubation
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.
PROCEDUREBronchoscope-guided intubation
Routine bronchoscope- guided intubation.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to success | At once after performing intubation at the first attempt and confirming successful endotracheal intubation by capnography | Time taken in seconds to successful intubation at the first-attempt |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The first-attempt success | At once after the first-attempt and confirmed by capnography.. | Intubation at the first attempt is whether successful or failure, confirmed by capnography. |
| Overall success | At once after procedure and confirmed by capnography. | Intubation is whether successful or failure within no more than 2 attempts and no more than 600 seconds, confirmed by capnography. |
| Procedure time | Whiler performing intubation. | Accumulation of every attempts (no more than 2) from bronchoscope passage of teeth to tube well placed. |
| Satisfaction with visualizaiton | At once after every attempt before confirmed by capnography | Satisfaction with visualization estimated by performers. |
| Intubation relative complications | At once after performing procedure and after extubation. | Including desaturation (\<90%), obvious trauma ,bloody secretions, post-extuvation hoarseness and sore throat. |
| Number of attempts | While performing the procedure | Number of attempts to fulfill intubation |
Countries
China
Outcome results
None listed