MGPOCUS Assisted Bronchoscopy in Difficult Endotracheal Intubation

Peking Union Medical College Hospital350 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

350

Conditions

Airway Management

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Time to success

Time taken in seconds to successful intubation at the first-attempt

Time frame: At once after performing intubation at the first attempt and confirming successful endotracheal intubation by capnography

Secondary Outcomes

Procedure time

Accumulation of every attempts (no more than 2) from bronchoscope passage of teeth to tube well placed.

Time frame: Whiler performing intubation.

The first-attempt success

Intubation at the first attempt is whether successful or failure, confirmed by capnography.

Time frame: 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.

Time frame: At once after procedure and confirmed by capnography.

Number of attempts

Number of attempts to fulfill intubation

Time frame: While performing the procedure

Satisfaction with visualizaiton

Satisfaction with visualization estimated by performers.

Time frame: 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.

Time frame: At once after performing procedure and after extubation.