MGPOCUS Assisted Bronchoscopy in Difficult Endotracheal Intubation

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05647174
• Other study ID #: MGPOCUS-DTI
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: March 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: March 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Airway Management

Intervention

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.
• Bronchoscope-guided intubation
Routine bronchoscope- guided intubation.

Locations

Country	Name	City	State
China	Peing Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Procedure time	Accumulation of every attempts (no more than 2) from bronchoscope passage of teeth to tube well placed.	Whiler performing intubation.
Secondary	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..
Secondary	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.
Secondary	Number of attempts	Number of attempts to fulfill intubation	While performing the procedure
Secondary	Satisfaction with visualizaiton	Satisfaction with visualization estimated by performers.	At once after every attempt before confirmed by capnography
Secondary	Intubation relative complications	Including desaturation (<90%), obvious trauma ,bloody secretions, post-extuvation hoarseness and sore throat.	At once after performing procedure and after extubation.