MGPOCUS Assisted Bronchoscopy in Difficult Endotracheal Intubation

NCT05647174 | Not Yet Recruiting DMC

• 1 other identifier: MGPOCUS-DTI
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Procedure time

  Whiler performing intubation.

• The first-attempt success

  At once after the first-attempt and confirmed by capnography..

• Overall success

  At once after procedure and confirmed by capnography.

• Number of attempts

  While performing the procedure

• Satisfaction with visualizaiton

  At once after every attempt before confirmed by capnography

Study Arms (2)

MGPOCUS-assisted bronchoscope-guided intubation

ACTIVE COMPARATOR

Procedure: MGPOCUS-assisted bronchoscope-guided intubation

Bronchoscope-guided Intubation

EXPERIMENTAL

Procedure: Bronchoscope-guided intubation

Interventions

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.

MGPOCUS-assisted bronchoscope-guided intubation

Bronchoscope-guided intubation PROCEDURE

Routine bronchoscope- guided intubation.

Bronchoscope-guided Intubation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peing Union Medical College Hospital

Beijing, 100730, China

Location

Related Publications (1)

• 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.

  PMID: 37369409 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2022
• First Posted: December 12, 2022
• Study Start: August 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: April 4, 2023

Record last verified: 2023-03

Locations

CN (1)