MGPOCUS Assisted Bronchoscopy in Difficult Endotracheal Intubation

Not Applicable

Not yet recruiting

• Conditions: Airway Management
• Interventions: Procedure: MGPOCUS-assisted bronchoscope-guided intubation; Procedure: Bronchoscope-guided intubation

• Registration Number: NCT05647174
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-03
• Study First Submitted QC: 2022-12-03
• Study First Posted: 2022-12-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-04-04
• Study Start: 2023-08-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MGPOCUS-assisted bronchoscope-guided intubation	MGPOCUS-assisted bronchoscope-guided intubation	-
Bronchoscope-guided Intubation	Bronchoscope-guided intubation	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Procedure time	Whiler performing intubation.	Accumulation of every attempts (no more than 2) from bronchoscope passage of teeth to tube well placed.
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.
Number of attempts	While performing the procedure	Number of attempts to fulfill intubation
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.
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.

Trial Locations

Locations (1)

Peing Union Medical College Hospital; 🇨🇳 Beijing, China