IntubationNCT02997488
Comparison of Routine Endotracheal Intubation With McGrath Videolaryngoscope and Pentax AirwayScope
An observational study of Intubation, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Recently many kinds of indirect videolaryngoscopes were developed. These videolaryngoscopes provide easier intubation, help intubation difficulty, are used good tool for education. McGrath Videolaryngoscope and Pentax AirwayScope are kinds of these videolaryngoscopes. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Intubation
- What is being tested?
- Pentax Airwayscope and McGrath Videolaryngoscope
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Feb 2017to 14 Jun 2017
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients scheduled for elective surgery requiring orotracheal intubation in our hospital
Who may be able to join
- an American Society of Anesthesiologists physical status (ASA) 1 or 2
Who cannot join
- a suspected difficult airway (Mallampati score Ⅳ)
- known cervical spine injury
- required rapid sequence induction
- emergency operation
Trial locations and contacts
1 site in 1 country.
About this study
Recently many kinds of indirect videolaryngoscopes were developed. These videolaryngoscopes provide easier intubation, help intubation difficulty, are used good tool for education. McGrath Videolaryngoscope and Pentax AirwayScope are kinds of these videolaryngoscopes.
The purpose of this study is to compare of routine endotracheal intubation with McGrath Videolaryngoscope and Pentax AirwayScope by means of providing better laryngeal view, easier and faster intubation.
- Conditions
- Intubation
- Being tested
- Pentax Airwayscope, McGrath Videolaryngoscope
- Keywords
- videolaryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentax AirwayscopeDevice
intubation using Pentax Airwayscope
McGrath VideolaryngoscopeDevice
intubation using McGrath Videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| McGrath | McGrath Videolaryngoscope Receives: Device: McGrath Videolaryngoscope | |
| Pentax | Pentax Airwayscope Receives: Device: Pentax Airwayscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubation
from entering of blade between incisors to appearance of first end tidal CO2 curve using capnograph
Measured: 10 minutes around intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start9 Feb 2017
- Primary completion14 Jun 2017
- Study completion14 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiyoung Lee, Ajou University School of Medicine
- Investigators
- Jiyoung Lee, MD, Principal investigator, Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997488
- Sponsor's protocol ID
- AJIRB-DEV-OBS-16-473
- Status last verified
- Jun 2017
- First submitted
- 14 Dec 2016
- Last updated
- 15 Jun 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Routine Endotracheal Intubation With McGrath Videolaryngoscope and Pentax AirwayScope
- ClinicalTrials.gov ID
- NCT02997488
- Acronym / sponsor ID
- AJIRB-DEV-OBS-16-473
- Conditions
- Intubation
- Keywords
- videolaryngoscope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 20 Dec 2016 (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.
Recently many kinds of indirect videolaryngoscopes were developed. These videolaryngoscopes provide easier intubation, help intubation difficulty, are used good tool for education. McGrath Videolaryngoscope and Pentax AirwayScope are kinds of these videolaryngoscopes.
The purpose of this study is to compare of routine endotracheal intubation with McGrath Videolaryngoscope and Pentax AirwayScope by means of providing better laryngeal view, easier and faster intubation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| McGrath | – | Device: McGrath VideolaryngoscopeMcGrath Videolaryngoscope |
| Pentax | – | Device: Pentax AirwayscopePentax Airwayscope |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for elective surgery requiring orotracheal intubation in our hospital
Key inclusion criteria (1 listed)
- an American Society of Anesthesiologists physical status (ASA) 1 or 2
Key exclusion criteria (4 listed)
- a suspected difficult airway (Mallampati score Ⅳ)
- known cervical spine injury
- required rapid sequence induction
- emergency 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 |
|---|---|---|
| Pentax Airwayscopeintubation using Pentax Airwayscope | Device | Pentax |
| McGrath Videolaryngoscopeintubation using McGrath Videolaryngoscope | Device | McGrath |
Primary outcome
Time to intubation
Time frame: 10 minutes around intubation
from entering of blade between incisors to appearance of first end tidal CO2 curve using capnograph
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 15 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Intubation
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Recruiting
Vagal Stimulator to Reduce Nasogastric Tube Use
Nasogastric Tube Intubation
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
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.
Jiyoung Lee, MD principal investigator
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation, run by Ajou University School of Medicine 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 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 15 Jun 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 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?
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?
Time to intubation (time frame: 10 minutes around 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 15 Jun 2017.