Intubation; Difficult or FailedNCT05006651
Video Laryngoscope vs. Video Stylet During General Anesthesia With Obesity Patient
A study testing McGrath MAC and Trachway in people with Intubation; Difficult or Failed and Obesity, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
Obesity patients are more common in recent years. They have potential difficult airway. Two different video devices are popular used in Taiwan, video larygoscope and video stylet. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Intubation; Difficult or Failed, Obesity
- What is being tested?
- McGrath MAC and Trachway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Aug 2021to 31 Jul 2024
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery needs intubation
- ASA I to III
- BMI>30kg/m2
Who cannot join
- Head and neck cancer
- Skull, neck fracture
- Tracheal trauma
- NPO< 8hr
- Lung disease with hypoxemia
- Mental Disorders
- Patient wouldn't be extubated after operation immediately
- Contraindicated to muscle relaxant
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Hualien Tzu Chi Hospital
Hualien City, Hualien, 970
Hualien Tzu Chi Hospital, +8863-8561825
About this study
Obesity patients are more common in recent years. They have potential difficult airway. Two different video devices are popular used in Taiwan, video larygoscope and video stylet. We compared video larygoscope (McGrath MAC) and video stylet (Trachway) during elective surgery require tracheal intubation with obesity patients. The control group is traditional laryngoscope. 325 patients would be enrolled, above 100 patient each group.
- Conditions
- Intubation; Difficult or Failed, Obesity
- Being tested
- McGrath MAC, Trachway
- Keywords
- obesity, Intubation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGrath MACDevice
Intubaion with McGrath MAC
TrachwayDevice
Intubaion with Trachway
| Study group | Role | What they receive |
|---|---|---|
| Laryngoscope | No intervention | Intubation with traditional laryngoscope |
| McGrath MAC | Active comparator | Intubation with video laryngoscope Receives: Device: McGrath MAC |
| Trachway | Active comparator | Intubation with video stylet Receives: Device: Trachway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Intubation
Total intubation duration
Measured: 10 minute
Intubation difficulty
Including Intubation difficulty scale, inubation attempt times, number of operator
Measured: 10 minute
Secondary outcomes (1)
Any injury during intubation
Including sore throat, hoarseness, trauma
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start4 Aug 2021
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Po-Kai Wang, Study chair, Hualien Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006651
- Sponsor's protocol ID
- IRB109-265-A
- Status last verified
- Aug 2021
- First submitted
- 8 Aug 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Laryngoscope vs. Video Stylet During General Anesthesia With Obesity Patient
- ClinicalTrials.gov ID
- NCT05006651
- Acronym / sponsor ID
- IRB109-265-A
- Conditions
- Intubation; Difficult or Failed, Obesity
- Keywords
- obesity, Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 16 Aug 2021 (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.
Obesity patients are more common in recent years. They have potential difficult airway. Two different video devices are popular used in Taiwan, video larygoscope and video stylet. We compared video larygoscope (McGrath MAC) and video stylet (Trachway) during elective surgery require tracheal intubation with obesity patients. The control group is traditional laryngoscope. 325 patients would be enrolled, above 100 patient each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laryngoscope | No intervention | –Intubation with traditional laryngoscope |
| McGrath MAC | Active comparator | Device: McGrath MACIntubation with video laryngoscope |
| Trachway | Active comparator | Device: TrachwayIntubation with video stylet |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective surgery needs intubation
- ASA I to III
- BMI>30kg/m2
Key exclusion criteria (8 listed)
- Head and neck cancer
- Skull, neck fracture
- Tracheal trauma
- NPO< 8hr
- Lung disease with hypoxemia
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 |
|---|---|---|
| McGrath MACIntubaion with McGrath MAC | Device | McGrath MAC |
| TrachwayIntubaion with Trachway | Device | Trachway |
Primary outcome
Time to Intubation
Time frame: 10 minute
Total intubation duration
Intubation difficulty
Time frame: 10 minute
Including Intubation difficulty scale, inubation attempt times, number of operator
1 secondary outcome
Any injury during intubation
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Po-Kai Wang study chair
Hualien Tzu Chi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McGrath MAC and Trachway in people with Intubation; Difficult or Failed and Obesity, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
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 3 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 16 Aug 2021. 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 Taiwan. 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?
Contact Ching-Hsuan Huang (+8863-8561825 ext. 14360, velociraptor4226@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Intubation (time frame: 10 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2021.