AnesthesiaNCT01824914
Airway Evaluation by McGrath Videolaryngoscope
A study testing McGrath Videolaryngoscope in people with Anesthesia, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Difficult tracheal intubation is a cause of severe patient damage and death. There is not a good method to predict it. The McGrath Series 5 video laryngoscope can improve visualization of the glottic structures one to two grades. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- McGrath Videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Oct 2013
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients scheduled for general surgery under general anesthesia
- ASA classification 1-3
Who cannot join
- emergent operation, aspiration risk
- a history of difficult airway
- expected difficult airway
- incooperative patients with mental diseases, hearing disorders
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: Comparison of Cormack-Lehane Score in Sedation and Anesthesia Condition by McGrath Videolaryngoscope
Difficult tracheal intubation is a cause of severe patient damage and death. There is not a good method to predict it. The McGrath Series 5 video laryngoscope can improve visualization of the glottic structures one to two grades. Moreover unlike a classical laryngoscope with a Macintosh blade, the McGrath provides a view of the glottis without requiring alignment of the oral, pharyngeal and laryngeal axes. In this study, the investigators will use it to compare the Cormack-Lehane score in sedation and anesthesia condition. It helps to know the role of videolaryngoscope in predicting difficult intubation.
Read the detailed description
- The enrolled patients were given a bolus of sufentanil 0.3-0.5μg/kg to achieve Ramsay sedation score 2-3. The Cormack-Lehane score in sedation was evaluated by McGrath videolaryngoscope.
- Then the patients were induced with propofol. A bolus of rocuronium was given to facilitate intubation. The Cormack-Lehane score in anesthesia was recorded when intubated by McGrath videolaryngoscope.
- BMI, mouth opening, thyromental distance, intubation duration and ramsay sedation score were also recorded.
- To compare the Cormack-Lehane score in sedate and anesthesia condition
- Conditions
- Anesthesia
- Being tested
- McGrath Videolaryngoscope
- Keywords
- videolaryngoscope, tracheal intubation, Cormack-Lehane grade, airway evaluation, sedation, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGrath VideolaryngoscopeDevice
A kind of portable videolaryngoscopes, produced by Aircraft Medical. It has been used for difficult airway.
| Study group | Role | What they receive |
|---|---|---|
| McGrath Videolaryngoscope | Experimental | to compare the Cormack-Lehane grade in sedation and anesthesia by McGrath videolaryngoscope Receives: Device: McGrath Videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cormack-Lehane score in sedation condition
Based on the Modified Cormack-Lehane classification. 5 degrades. 1-5
Measured: 5 minutes after administration of sufentanil
Cormack-lehane score in anesthesia condition
Based on the Modified Cormack-Lehane classification. 5 degrades. 1-5
Measured: 1 minute after administration of rocuronium
Secondary outcomes (2)
Duration of intubation
The duration of intubation is defined as the time from inserting videolaryngoscope, intubating a tube, to withdrawing videolaryngoscope using a stopwatch.
Measured: At intubation
Sedation score
by Ramsay sedation score 1-6. The higher score, the deeper sedation
Measured: 5 minutes after administraion of sufentanil
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 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, Ph.D.,M.D., Study director, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824914
- Sponsor's protocol ID
- TJMZK20121231
- Status last verified
- Nov 2014
- First submitted
- 25 Mar 2013
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cormack-Lehane Score in Sedation and Anesthesia Condition by McGrath Videolaryngoscope
- ClinicalTrials.gov ID
- NCT01824914
- Acronym / sponsor ID
- TJMZK20121231
- Conditions
- Anesthesia
- Keywords
- videolaryngoscope, tracheal intubation, Cormack-Lehane grade, airway evaluation, sedation, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 5 Apr 2013 (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.
Difficult tracheal intubation is a cause of severe patient damage and death. There is not a good method to predict it. The McGrath Series 5 video laryngoscope can improve visualization of the glottic structures one to two grades. Moreover unlike a classical laryngoscope with a Macintosh blade, the McGrath provides a view of the glottis without requiring alignment of the oral, pharyngeal and laryngeal axes. In this study, the investigators will use it to compare the Cormack-Lehane score in sedation and anesthesia condition. It helps to know the role of videolaryngoscope in predicting difficult intubation.
Detailed description
- The enrolled patients were given a bolus of sufentanil 0.3-0.5μg/kg to achieve Ramsay sedation score 2-3. The Cormack-Lehane score in sedation was evaluated by McGrath videolaryngoscope.
- Then the patients were induced with propofol. A bolus of rocuronium was given to facilitate intubation. The Cormack-Lehane score in anesthesia was recorded when intubated by McGrath videolaryngoscope.
- BMI, mouth opening, thyromental distance, intubation duration and ramsay sedation score were also recorded.
- To compare the Cormack-Lehane score in sedate and anesthesia condition
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| McGrath Videolaryngoscope | Experimental | Device: McGrath Videolaryngoscopeto compare the Cormack-Lehane grade in sedation and anesthesia by McGrath videolaryngoscope |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients scheduled for general surgery under general anesthesia
- ASA classification 1-3
Key exclusion criteria (4 listed)
- emergent operation, aspiration risk
- a history of difficult airway
- expected difficult airway
- incooperative patients with mental diseases, hearing disorders
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 VideolaryngoscopeA kind of portable videolaryngoscopes, produced by Aircraft Medical. It has been used for difficult airway. | Device | McGrath Videolaryngoscope |
Primary outcome
Cormack-Lehane score in sedation condition
Time frame: 5 minutes after administration of sufentanil
Based on the Modified Cormack-Lehane classification. 5 degrades. 1-5
Cormack-lehane score in anesthesia condition
Time frame: 1 minute after administration of rocuronium
Based on the Modified Cormack-Lehane classification. 5 degrades. 1-5
2 secondary outcomes
Duration of intubation
Time frame: At intubation
Sedation score
Time frame: 5 minutes after administraion of sufentanil
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 7 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, Ph.D.,M.D. study director
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 study testing McGrath Videolaryngoscope in people with Anesthesia, 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 7 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.
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?
Cormack-Lehane score in sedation condition (time frame: 5 minutes after administration of sufentanil). 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 7 Nov 2014.