Anesthesia, GeneralNCT03516539
Mcgrath Videolaryngoscope Versus Macintosh Laryngoscope in Patients With Manual In-line Stabilization
A study testing Group ML and Group DL in people with Anesthesia, General, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
Video laryngoscopy provides easily a good laryngeal view compared to direct laryngoscopy. It is particularly, useful in patients with anticipated difficult intubation, and also widely used for educational purposes. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Group ML and Group DL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Dec 2017to 7 Jul 2018
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for general anesthesia requiring tracheal intubation. Patients are aged 19 to 70 years and are American Society of Anesthesiologists physical status I, II.
Who cannot join
- Patients requiring rapid sequence intubation Patients with poor teeth or high risk of aspiration pneumonia Cervical spine pathology, pharyngeal pathology
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 14068
Yi Hwa Choi, Dr, 82-31-380-3813 ext. 3946, pcyhchoi@hallym.or.kr
About this study
Official title: Comparison of the Mcgrath Videolaryngoscope With the Macintosh Laryngoscope for Orotracheal Intubation in Patients With Manual In-line Stabilization
Video laryngoscopy provides easily a good laryngeal view compared to direct laryngoscopy. It is particularly, useful in patients with anticipated difficult intubation, and also widely used for educational purposes. Among video laryngoscopy, Mcgrath is a recently-developed, portable video laryngoscopy with a liquid crystal display (LCD) monitor and disposable curved blade.
Mcgrath is known to provide excellent laryngeal visibility even in case of anticipated-difficult and anticipated-unsuccessful intubation as well as normal airway management. However, compared with direct laryngoscopy, the success rate of intubation and the time required for anticipated difficult intubation have been reported conflicting results in previous studies. The aim of this study was to compare the intubation success rate, the intubation time and the ease of use with Mcgrath video laryngoscopy and direct laryngoscopy during intubation.
Read the detailed description
- In the operating room, all patients are monitored with an electrocardiograph, noninvasive blood pressure, pulse oximeter, capnograph and Bispectral index (BIS) monitor. After pre-oxygenation with 100% oxygen for 1 minute, intravenous anesthesia (TIVA) with propofol and remifentanyl is administrated and followed by rocuronium (0.6mg/kg). When patients are lost their consciousness, manual mask ventilation is proceeded with 100% oxygen for 2 minutes.
- Transoral endotracheal intubation is performed using Mcgrath videolaryngoscope (Group ML) and direct laryngoscope (Group DL) using manual in-line stabilization. At this time, the time required for intubation is measure by other medical personnel not engaged in this research.
- The anesthesiologist assesses Cormack Lehane laryngeal visual field,external laryngeal manipulation, intubation difficulty scales (IDS) and the difficulty of intubation.
- Conditions
- Anesthesia, General
- Being tested
- Group ML, Group DL
- Keywords
- Videolaryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group MLDevice
Mcgrath videolaryngoscope
Group DLDevice
Macintosh laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Group ML | Experimental | Mcgrath videolaryngoscopy Receives: Device: Group ML |
| Group DL | Active comparator | direct Macintosh laryngoscope Receives: Device: Group DL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation success rate
success or failure of intubation
Measured: 1 hour
Secondary outcomes (3)
Time required for intubation
time until end tidal carbon dioxide (CO2) measurement after laryngeal blade passing through patient's teeth
Measured: 1 hour
Intubation difficulty score
difficulty at the time of intubation. (easy /moderate/ difficult)
Measured: 1 hour
Complications
oral bleeding, teeth or lip bleeding
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start11 Dec 2017
- Primary completion30 Jun 2018 (estimated)
- Study completion7 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Hwa Choi, Dr, Study director, Halllym university Sacred Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516539
- Sponsor's protocol ID
- 2017-I043
- Status last verified
- Apr 2018
- First submitted
- 24 Apr 2018
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rai MR, Dering A, Verghese C. The Glidescope system: a clinical assessment of performance. Anaesthesia. 2005 Jan;60(1):60-4. doi: 10.1111/j.1365-2044.2004.04013.x.
PubMed 15601274Asai T, Murao K, Shingu K. Training method of applying pressure on the neck for laryngoscopy: use of a videolaryngoscope. Anaesthesia. 2003 Jun;58(6):602-3. doi: 10.1046/j.1365-2044.2003.03207_7.x. No abstract available.
PubMed 12846635Shippey B, Ray D, McKeown D. Case series: the McGrath videolaryngoscope--an initial clinical evaluation. Can J Anaesth. 2007 Apr;54(4):307-13. doi: 10.1007/BF03022777.
PubMed 17400984Shippey B, Ray D, McKeown D. Use of the McGrath videolaryngoscope in the management of difficult and failed tracheal intubation. Br J Anaesth. 2008 Jan;100(1):116-9. doi: 10.1093/bja/aem303. Epub 2007 Oct 23.
PubMed 17959584
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Mcgrath Videolaryngoscope With the Macintosh Laryngoscope for Orotracheal Intubation in Patients With Manual In-line Stabilization
- ClinicalTrials.gov ID
- NCT03516539
- Acronym / sponsor ID
- 2017-I043
- Conditions
- Anesthesia, General
- Keywords
- Videolaryngoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 7 Jul 2018 (estimated)
- First posted
- 4 May 2018 (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.
Video laryngoscopy provides easily a good laryngeal view compared to direct laryngoscopy. It is particularly, useful in patients with anticipated difficult intubation, and also widely used for educational purposes. Among video laryngoscopy, Mcgrath is a recently-developed, portable video laryngoscopy with a liquid crystal display (LCD) monitor and disposable curved blade.
Mcgrath is known to provide excellent laryngeal visibility even in case of anticipated-difficult and anticipated-unsuccessful intubation as well as normal airway management. However, compared with direct laryngoscopy, the success rate of intubation and the time required for anticipated difficult intubation have been reported conflicting results in previous studies. The aim of this study was to compare the intubation success rate, the intubation time and the ease of use with Mcgrath video laryngoscopy and direct laryngoscopy during intubation.
Detailed description
- In the operating room, all patients are monitored with an electrocardiograph, noninvasive blood pressure, pulse oximeter, capnograph and Bispectral index (BIS) monitor. After pre-oxygenation with 100% oxygen for 1 minute, intravenous anesthesia (TIVA) with propofol and remifentanyl is administrated and followed by rocuronium (0.6mg/kg). When patients are lost their consciousness, manual mask ventilation is proceeded with 100% oxygen for 2 minutes.
- Transoral endotracheal intubation is performed using Mcgrath videolaryngoscope (Group ML) and direct laryngoscope (Group DL) using manual in-line stabilization. At this time, the time required for intubation is measure by other medical personnel not engaged in this research.
- The anesthesiologist assesses Cormack Lehane laryngeal visual field,external laryngeal manipulation, intubation difficulty scales (IDS) and the difficulty of 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 |
|---|---|---|
| Group ML | Experimental | Device: Group MLMcgrath videolaryngoscopy |
| Group DL | Active comparator | Device: Group DLdirect Macintosh laryngoscope |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for general anesthesia requiring tracheal intubation. Patients are aged 19 to 70 years and are American Society of Anesthesiologists physical status I, II.
Key exclusion criteria (1 listed)
- Patients requiring rapid sequence intubation Patients with poor teeth or high risk of aspiration pneumonia Cervical spine pathology, pharyngeal pathology
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 |
|---|---|---|
| Group MLMcgrath videolaryngoscope | Device | Group ML |
| Group DLMacintosh laryngoscope | Device | Group DL |
Primary outcome
Intubation success rate
Time frame: 1 hour
success or failure of intubation
3 secondary outcomes
Time required for intubation
Time frame: 1 hour
Intubation difficulty score
Time frame: 1 hour
Complications
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Background: PubMed 15601274Rai MR, Dering A, Verghese C. The Glidescope system: a clinical assessment of performance. Anaesthesia. 2005 Jan;60(1):60-4. doi: 10.1111/j.1365-2044.2004.04013.x.
- Background: PubMed 12846635Asai T, Murao K, Shingu K. Training method of applying pressure on the neck for laryngoscopy: use of a videolaryngoscope. Anaesthesia. 2003 Jun;58(6):602-3. doi: 10.1046/j.1365-2044.2003.03207_7.x. No abstract available.
- Results publication: PubMed 17400984Shippey B, Ray D, McKeown D. Case series: the McGrath videolaryngoscope--an initial clinical evaluation. Can J Anaesth. 2007 Apr;54(4):307-13. doi: 10.1007/BF03022777.
- Results publication: PubMed 17959584Shippey B, Ray D, McKeown D. Use of the McGrath videolaryngoscope in the management of difficult and failed tracheal intubation. Br J Anaesth. 2008 Jan;100(1):116-9. doi: 10.1093/bja/aem303. Epub 2007 Oct 23.
- Individual participant dataSharing planned: Undecided
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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.
Yi Hwa Choi, Dr study director
Halllym university Sacred 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 Group ML and Group DL in people with Anesthesia, General, run by Hallym University Medical Center at 1 site in South Korea.
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 1 inclusion and 1 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 May 2018. 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 South Korea. 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 Yi Hwa Choi, Dr. (82-31-380-3813 ext. 9346, pcyhchoi@hallym.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation success rate (time frame: 1 hour). 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 NCT03516539, which also lists 4 linked publications.
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 May 2018.