Videolaryngoscopes (VL)NCT02991820
VL vs DL in Inexperienced Users: a Pediatric Manikin Study
A study testing Miller, Macintosh and C-MAC in people with Videolaryngoscopes (VL) and Direct Laryngoscopy (DL), run by Joseph D. Tobias at 1 site in United States.
Trial summary
This study will compare the CMAC and Glidescope videolaryngoscopes (VL) to traditional direct laryngoscopy (DL) using either a Miller or Macintosh laryngoscope by studying the performance of users. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Videolaryngoscopes (VL), Direct Laryngoscopy (DL), Inexperienced Users
- What is being tested?
- Miller, Macintosh and C-MAC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Faculty pediatric anesthesiologists
- CRNAs
- Trainees (SRNAs, residents, fellows, and medical students)
- Nurses from NCH
Who cannot join
- If subjects are unwilling to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Comparison of Miller and Macintosh Laryngoscopes, CMAC and Glidescope Videolaryngoscopes in Inexperienced Users: a Pediatric Manikin Study
This study will compare the CMAC and Glidescope videolaryngoscopes (VL) to traditional direct laryngoscopy (DL) using either a Miller or Macintosh laryngoscope by studying the performance of users. This will involve the use of an intubating pediatric manikin to assess various aspects of endotracheal intubation by experienced and inexperienced users.
Read the detailed description
The commonly used method for endotracheal intubation in children is direct laryngoscopy using a Miller or Macintosh blade. Videolaryngoscopy is a widely accepted pediatric airway management. Videolaryngoscopes (VL) provide an indirect view of glottis without the need to align the oral, pharyngeal, and glottis structures. Some types of VLs provide also direct view of glottis with indirect view. Videolaryngoscopes can be used as a teaching tool for learners as they can visualize all the anatomical structures of larynx at the same time with the performer. VLs may facilitate the learning of endotracheal intubation in inexperienced users in the pediatric population. There are limited data on the use of videolaryngoscopes by anesthesia providers and medical personnel who are inexperienced in the use of videolaryngoscopes.
- Being tested
- Miller, Macintosh, C-MAC, GlideScope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MillerDevice
Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope
MacintoshDevice
Direct laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope
C-MACDevice
Indirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope
GlideScopeDevice
Indirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Inexperienced users | Experimental | Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH. Receives: Device: Miller; Device: Macintosh; Device: C-MAC; Device: GlideScope |
| Experienced users | Experimental | Experienced users will include faculty pediatric anesthesiologists CRNAs. Receives: Device: Miller; Device: Macintosh; Device: C-MAC; Device: GlideScope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Endotracheal Intubation
The amount of time it took to successfully intubate the manikin using each device.
Measured: the same day (within seconds to minutes)
Secondary outcomes (1)
Successful Intubation Within 120 Seconds
The number of participants who were able to successfully intubate the manikin using each device within 120 seconds.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Videolaryngoscopes (VL)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph D. Tobias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph D. Tobias, Nationwide Children's Hospital
- Investigators
- Joseph Tobias, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991820
- Sponsor's protocol ID
- IRB16-00549
- Status last verified
- Jul 2018
- First submitted
- 6 Dec 2016
- Last updated
- 18 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Miller and Macintosh Laryngoscopes, CMAC and Glidescope Videolaryngoscopes in Inexperienced Users: a Pediatric Manikin Study
- ClinicalTrials.gov ID
- NCT02991820
- Acronym / sponsor ID
- IRB16-00549
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Joseph D. TobiasUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Posted 18 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the CMAC and Glidescope videolaryngoscopes (VL) to traditional direct laryngoscopy (DL) using either a Miller or Macintosh laryngoscope by studying the performance of users. This will involve the use of an intubating pediatric manikin to assess various aspects of endotracheal intubation by experienced and inexperienced users.
Detailed description
The commonly used method for endotracheal intubation in children is direct laryngoscopy using a Miller or Macintosh blade. Videolaryngoscopy is a widely accepted pediatric airway management. Videolaryngoscopes (VL) provide an indirect view of glottis without the need to align the oral, pharyngeal, and glottis structures. Some types of VLs provide also direct view of glottis with indirect view. Videolaryngoscopes can be used as a teaching tool for learners as they can visualize all the anatomical structures of larynx at the same time with the performer. VLs may facilitate the learning of endotracheal intubation in inexperienced users in the pediatric population. There are limited data on the use of videolaryngoscopes by anesthesia providers and medical personnel who are inexperienced in the use of videolaryngoscopes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inexperienced users | Experimental | Device: Miller, Device: Macintosh, Device: C-MAC, Device: GlideScopeInexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH. |
| Experienced users | Experimental | Device: Miller, Device: Macintosh, Device: C-MAC, Device: GlideScopeExperienced users will include faculty pediatric anesthesiologists CRNAs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Faculty pediatric anesthesiologists
- CRNAs
- Trainees (SRNAs, residents, fellows, and medical students)
- Nurses from NCH
Key exclusion criteria (1 listed)
- If subjects are unwilling to participate.
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 |
|---|---|---|
| MillerDirect laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope | Device | Experienced users, Inexperienced users |
| MacintoshDirect laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope | Device | Experienced users, Inexperienced users |
| C-MACIndirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope | Device | Experienced users, Inexperienced users |
| GlideScopeIndirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope | Device | Experienced users, Inexperienced users |
Primary outcome
Time to Endotracheal Intubation
Time frame: the same day (within seconds to minutes)
The amount of time it took to successfully intubate the manikin using each device.
1 secondary outcome
Successful Intubation Within 120 Seconds
Time frame: 2 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Joseph Tobias, MD principal investigator
Nationwide Children's 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 Miller, Macintosh and C-MAC in people with Videolaryngoscopes (VL) and Direct Laryngoscopy (DL), run by Joseph D. Tobias at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 18 Jul 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Endotracheal Intubation (time frame: the same day (within seconds to minutes)). 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 18 Jul 2018.