Airway ManagementNCT05647174
MGPOCUS Assisted Bronchoscopy in Difficult Endotracheal Intubation
A study testing MGPOCUS-assisted bronchoscope-guided intubation and Bronchoscope-guided intubation in people with Airway Management, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Airway Management
- What is being tested?
- MGPOCUS-assisted bronchoscope-guided intubation and Bronchoscope-guided intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Airway Management
- Being tested
- MGPOCUS-assisted bronchoscope-guided intubation, Bronchoscope-guided intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGPOCUS-assisted bronchoscope-guided intubationProcedure or surgery
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 intubationProcedure or surgery
Routine bronchoscope- guided intubation.
| Study group | Role | What they receive |
|---|---|---|
| MGPOCUS-assisted bronchoscope-guided intubation | Active comparator | Not described Receives: Procedure: MGPOCUS-assisted bronchoscope-guided intubation |
| Bronchoscope-guided Intubation | Experimental | Not described Receives: Procedure: Bronchoscope-guided intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to success
Time taken in seconds to successful intubation at the first-attempt
Measured: At once after performing intubation at the first attempt and confirming successful endotracheal intubation by capnography
Secondary outcomes (6)
Procedure time
Accumulation of every attempts (no more than 2) from bronchoscope passage of teeth to tube well placed.
Measured: Whiler performing intubation.
The first-attempt success
Intubation at the first attempt is whether successful or failure, confirmed by capnography.
Measured: 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.
Measured: At once after procedure and confirmed by capnography.
Number of attempts
Number of attempts to fulfill intubation
Measured: While performing the procedure
Satisfaction with visualizaiton
Satisfaction with visualization estimated by performers.
Measured: 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.
Measured: At once after performing procedure and after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Aug 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647174
- Sponsor's protocol ID
- MGPOCUS-DTI
- Status last verified
- Mar 2023
- First submitted
- 3 Dec 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data is available upon request from the corresponding author after the completion of the study.
Publications
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.
PubMed 37369409
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Magnetic-POCUS-assisted Bronchoscopy in Difficult Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT05647174
- Acronym / sponsor ID
- MGPOCUS-DTI
- Conditions
- Airway Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MGPOCUS-assisted bronchoscope-guided intubation | Active comparator | Procedure: MGPOCUS-assisted bronchoscope-guided intubation |
| Bronchoscope-guided Intubation | Experimental | Procedure: Bronchoscope-guided intubation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGPOCUS-assisted bronchoscope-guided intubationApplication 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. | Procedure or surgery | MGPOCUS-assisted bronchoscope-guided intubation |
| Bronchoscope-guided intubationRoutine bronchoscope- guided intubation. | Procedure or surgery | Bronchoscope-guided Intubation |
Primary outcome
Time to success
Time frame: 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
6 secondary outcomes
Procedure time
Time frame: Whiler performing intubation.
The first-attempt success
Time frame: At once after the first-attempt and confirmed by capnography..
Overall success
Time frame: At once after procedure and confirmed by capnography.
Number of attempts
Time frame: While performing the procedure
Satisfaction with visualizaiton
Time frame: At once after every attempt before confirmed by capnography
Intubation relative complications
Time frame: At once after performing procedure and after extubation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 37369409Tian 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.
- Individual participant dataSharing planned: Undecided. Data is available upon request from the corresponding author after the completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MGPOCUS-assisted bronchoscope-guided intubation and Bronchoscope-guided intubation in people with Airway Management, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to success (time frame: At once after performing intubation at the first attempt and confirming successful endotracheal intubation by capnography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05647174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.