MGPOCUS Assisted Bronchoscopy in Difficult Endotracheal Intubation

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

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 Overview

• Status: Not yet recruiting
• Conditions: Airway Management
• Intervention / Treatment: Procedure: MGPOCUS-assisted bronchoscope-guided intubation; Procedure: Bronchoscope-guided intubation

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Peing Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MGPOCUS-assisted bronchoscope-guided intubation	Procedure: MGPOCUS-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.
Experimental: Bronchoscope-guided Intubation	Procedure: Bronchoscope-guided intubation; Routine bronchoscope- guided intubation.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2023
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: December 3, 2022
• First Submitted That Met QC Criteria: December 3, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MGPOCUS-DTI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data is available upon request from the corresponding author after the completion of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No