Intubation;DifficultNCT02329041
Comparison of McGrath Series 5 and Airtraq Videolaryngoscope for Double-lumen Tube (DLT) Intubation
A study testing McGrath Series 5 and Airtraq in people with Intubation;Difficult and Thoracic Disease, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for double-lumen tube intubation. We have compared it with traditional Macintosh laryngoscopefor double-lumen tube intubation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intubation;Difficult, Thoracic Disease, Intubation Complication
- What is being tested?
- McGrath Series 5 and Airtraq
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to May 2016
- 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 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
- ASA physical status >4
- Emergent operation
- planned tracheotomy
- difficult intubation predicted by a simplified airway risk index score
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 of McGrath Series 5 and Airtraq Videolaryngoscope for Double-lumen Tube Intubation in Patients With Low Airway Risk Index Score
Previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for double-lumen tube intubation. We have compared it with traditional Macintosh laryngoscopefor double-lumen tube intubation. In this study, we will investigate its role in double-lumen tube intubation by comparison with another videolarygoscope.
Read the detailed description
The investigators designed a randomised controlled study to compare of McGrath Series 5 and Airtraq videolaryngoscope for DLT intubation in intubation time and the first attempt success rate.
- Being tested
- McGrath Series 5, Airtraq
- Keywords
- videolaryngoscope, double-lumen tube, 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.
McGrath Series 5Device
one kind of videolaryngoscopes, which are widely used in airway management.
AirtraqDevice
another kind of videolaryngoscopes, which are also widely used in airway management.
| Study group | Role | What they receive |
|---|---|---|
| McGrath Series 5 | Experimental | DLT intubation with McGrath Series 5 videolaryngoscope Receives: Device: McGrath Series 5 |
| Airtraq | Active comparator | DLT intubation with Airtraq videolaryngoscope Receives: Device: Airtraq |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
defined as time from inserting blade to mouth to withdrawal of blade, measured with a stopwatch
Measured: at intubation
Secondary outcomes (2)
number of successful intubation at first attempt
Measured: at intubation
total successful rate of DLT intubation
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 posted31 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionApr 2016
- Study completionMay 2016
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 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, yktian@tjh.tjmu.edu.cn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329041
- Sponsor's protocol ID
- TJMZK201412002
- Status last verified
- Apr 2017
- First submitted
- 21 Dec 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Because the article has not been published.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing of McGrath Series 5 and Airtraq Videolaryngoscope for Double-lumen Tube Intubation in Patients With Low Airway Risk Index Score
- ClinicalTrials.gov ID
- NCT02329041
- Acronym / sponsor ID
- TJMZK201412002
- Keywords
- videolaryngoscope, double-lumen tube, intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 31 Dec 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.
Previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for double-lumen tube intubation. We have compared it with traditional Macintosh laryngoscopefor double-lumen tube intubation. In this study, we will investigate its role in double-lumen tube intubation by comparison with another videolarygoscope.
Detailed description
The investigators designed a randomised controlled study to compare of McGrath Series 5 and Airtraq videolaryngoscope for DLT intubation in intubation time and the first attempt success rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| McGrath Series 5 | Experimental | Device: McGrath Series 5DLT intubation with McGrath Series 5 videolaryngoscope |
| Airtraq | Active comparator | Device: AirtraqDLT intubation with Airtraq videolaryngoscope |
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 (4 listed)
- ASA physical status >4
- Emergent operation
- planned tracheotomy
- difficult intubation predicted by a simplified airway risk index score
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 Series 5one kind of videolaryngoscopes, which are widely used in airway management. | Device | McGrath Series 5 |
| Airtraqanother kind of videolaryngoscopes, which are also widely used in airway management. | Device | Airtraq |
Primary outcome
Intubation time
Time frame: at intubation
defined as time from inserting blade to mouth to withdrawal of blade, measured with a stopwatch
2 secondary outcomes
number of successful intubation at first attempt
Time frame: at intubation
total successful rate of DLT intubation
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 4 Apr 2017.
- Individual participant dataSharing planned: No. Because the article has not been published.
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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
yktian@tjh.tjmu.edu.cn
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 Series 5 and Airtraq in people with Intubation;Difficult and Thoracic Disease, 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 4 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 4 Apr 2017. 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?
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 4 Apr 2017.