Intubation; DifficultPhase 4NCT02190201
Comparison of McGrath and Macintosh Laryngoscope for DLT Intubation
A Phase 4 study testing videolaryngoscope and Direct laryngoscope in people with Intubation; Difficult and Thoracic Diseases, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The investigators previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for double-lumen tube intubation. But it is not determined about the advantages and disadvantages of McGrath Series 5 videolaryngoscope for double-lumen tube intubation, compared with traditional Macintosh… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intubation; Difficult, Thoracic Diseases, Intubation Complication
- What is being tested?
- videolaryngoscope and Direct laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Nov 2014
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Thoracic surgery required one lung ventilation
Who cannot join
- Difficult ventilation
- Emergent operation
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: A Randomised Controlled Trial Comparing McGrath Series 5 Videolaryngoscope and Macintosh Laryngoscope for Double Lumen Tube Intubation
The investigators previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for double-lumen tube intubation. But it is not determined about the advantages and disadvantages of McGrath Series 5 videolaryngoscope for double-lumen tube intubation, compared with traditional Macintosh laryngoscope.
Read the detailed description
The investigators designed a randomised controlled study to compare of McGrath Series 5 videolaryngoscope and Macintosh laryngoscope for DLT intubation.
- Being tested
- videolaryngoscope, Direct laryngoscope
- Keywords
- videolaryngoscope, double lumen intubation
- Medical subject headings
- Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videolaryngoscopeDevice
Also called McGrath series 5 videolaryngoscope
a kind of videolaryngoscopes, which are widely used in difficult airways.
Direct laryngoscopeDevice
Also called Macintosh laryngoscopes
A kind of traditional laryngoscopes
| Study group | Role | What they receive |
|---|---|---|
| videolaryngoscope | Experimental | DLT intubation with McGrath videolaryngoscope Receives: Device: videolaryngoscope |
| Direct laryngoscope | Active comparator | DLT intubation with Macintosh laryngoscope Receives: Device: Direct laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
measured with a stopwatch, defined as time from inserting blade to mouth to withdrawal of blade
Measured: at intubation
Secondary outcomes (1)
number of successful intubation at first attempt
Measured: at intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; DifficultStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenlong Yao, Huazhong University of Science and Technology
- Investigators
- Yuke Tian, M.D., Study chair, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190201
- Sponsor's protocol ID
- TJMZK201405001
- Status last verified
- Nov 2014
- First submitted
- 10 Jul 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing McGrath Series 5 Videolaryngoscope and Macintosh Laryngoscope for Double Lumen Tube Intubation
- ClinicalTrials.gov ID
- NCT02190201
- Acronym / sponsor ID
- TJMZK201405001
- Keywords
- videolaryngoscope, double lumen intubation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 15 Jul 2014 (estimated)
- 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.
The investigators previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for double-lumen tube intubation. But it is not determined about the advantages and disadvantages of McGrath Series 5 videolaryngoscope for double-lumen tube intubation, compared with traditional Macintosh laryngoscope.
Detailed description
The investigators designed a randomised controlled study to compare of McGrath Series 5 videolaryngoscope and Macintosh laryngoscope for DLT intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| videolaryngoscope | Experimental | Device: videolaryngoscopeDLT intubation with McGrath videolaryngoscope |
| Direct laryngoscope | Active comparator | Device: Direct laryngoscopeDLT intubation with Macintosh laryngoscope |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients
- Thoracic surgery required one lung ventilation
Key exclusion criteria (2 listed)
- Difficult ventilation
- Emergent operation
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 |
|---|---|---|
| videolaryngoscopeAlso: McGrath series 5 videolaryngoscopea kind of videolaryngoscopes, which are widely used in difficult airways. | Device | videolaryngoscope |
| Direct laryngoscopeAlso: Macintosh laryngoscopesA kind of traditional laryngoscopes | Device | Direct laryngoscope |
Primary outcome
Intubation time
Time frame: at intubation
measured with a stopwatch, defined as time from inserting blade to mouth to withdrawal of blade
1 secondary outcome
number of successful intubation at first attempt
Time frame: at intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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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.
Yuke Tian, M.D. study chair
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing videolaryngoscope and Direct laryngoscope in people with Intubation; Difficult and Thoracic Diseases, run by Huazhong University of Science and Technology 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 21 Nov 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intubation time (time frame: at intubation). 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 21 Nov 2014.