Intubation; DifficultPhase 1NCT02198742
A Comparison Between Two Video Laryngoscopes,in Successfully Intubating Pediatric Mannequins w/wo Difficult Airways
A Phase 1 study testing Miller blade, Truview PCD and Glidescope Cobolt in people with Intubation; Difficult, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The study is a randomized crossover study where anesthesia practitioners will intubate three different pediatric infant mannequins (normal airway, anterior larynx, Pierre Robin syndrome anatomy) using three different intubation devices (the Miller blade, the Truview VL, the Glidescope Cobalt video-laryngoscope) in two… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- Miller blade, Truview PCD and Glidescope Cobolt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 2014
- Phase
- Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Anesthesia practitioners including anesthesia attendings, fellows, residents CAIII and CRNA's at Texas Children's Hospital Department of Anesthesiology with clinical experience of >500 intubations with Miller blades.
Who cannot join
- Anesthesia practitioners with <500 intubations with Miller blades.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Two Video Laryngoscopes,the Truview PCD and the Glidescope Cobalt AVL, in Successfully Intubating Pediatric Mannequins With and Without Difficult Airways
The study is a randomized crossover study where anesthesia practitioners will intubate three different pediatric infant mannequins (normal airway, anterior larynx, Pierre Robin syndrome anatomy) using three different intubation devices (the Miller blade, the Truview VL, the Glidescope Cobalt video-laryngoscope) in two different scenarios (normal neck and with an immobile neck). The order of presentation will be randomized. As this is a cross over study, all subjects will complete all scenarios. There is no placebo group, and each subject wil be his or her own control.
Read the detailed description
Participants will be given individual, standardized instructions and demonstrations for each device as per the manufacturers' instructions. The participants will practice with instructor's feedback on an infant mannequin with a normal airway until he/she feel comfortable with each of the three devices. The investigator will record the prior experience of the participant in using each of the 3 devices in clinical situations. Each subject will be asked to intubate each of the mannequins with each of the devices. The choice of the order of device and mannequin will be based on a Latin square design and the sequence will be assigned to participants based on a computer generated random number. A closed envelope technique will blind participants and investigators to the order of airway device and mannequin till the start of the individual trial. Participants will first finish the test on unchanged conditions and then repeat the process using the same order of mannequins and devices but with the neck held immobile to simulate a scenario of a child with an unstable cervical spine. Data from different scenarios will be recorded from a total number of 18 attempts of tracheal intubation per participant. Participants will be asked to proceed as though they were in the operating room with an assistant available to follow their commands. The order of presentation of each mannequin, airway device and scenario will be randomized as described above. The time from placing the device in the mannequin's mouth to the time the Ambu bag is connected to the end of the tracheal tube and a positive pressure breath is given will constitute the intubation time. During each intubation the participant will be asked to state when he or she has obtained the best view for intubation and this time this will be recorded as the time for visualization. The subject will assess the quality of the best glottic view on the Cormack - Lehane grade of 1 -4. The investigators will record all maneuvers to optimize visualization of the larynx such as tracheal pressure, lip retraction, pulling the tongue forward etc. The time from entry of the device in the mouth to the time the tracheal tube is started to be advanced is the visualization time. The time a positive pressure breath is given at the end of the tracheal tube will constitute the end of the attempt of intubation. A failed attempt is defined as removal of the laryngoscope from the mouth without a successful intubation. The number of times the endotracheal tube is advanced will also be recorded. Failure of intubation will be defined as unrecognized esophageal intubation, abandoned procedure, intubation taking longer than 120 seconds and intubation requiring more than 3 attempts. The observer will estimate the maximum force applied to the maxilla on a 0 -10 scale where 0= no force and 10 = maximum force with distortion of the maxilla. The observer will also estimate potential damage of laryngeal structures on a 0 -10 scale.
- Conditions
- Intubation; Difficult
- Being tested
- Miller blade, Truview PCD, Glidescope Cobolt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miller bladeDevice
To participate in the study the subjects must have >500 intubations with the miller blade.
Truview PCDDevice
Also called Trueview PCD - Multichoice video laryngoscope system
Subjects were given a quick guide of the Truview PCD supplied by the manufacturer with step by step instructions for use. They were also given time to practice with the device on a normal model until they felt comfortable.
Glidescope CoboltDevice
Subjects were required to watch a instructional video provided by the manufacturer. Subjects were then allowed to practice on a normal model until they felt comfortable before beginning the study. There is no placebo group, and each subject wil be his or her own control.
| Study group | Role | What they receive |
|---|---|---|
| Miller blade | Active comparator | Subjects must have >500 intubations in order to participate in this study. There is no placebo group, and each subject wil be his or her own control. Receives: Device: Miller blade |
| Truview PCD | Active comparator | Subjects were given a quick guide of the Truview PCD supplied by the manufacturer with step by step instructions for use. They were also given time to practice with the device on a normal model until they felt comfortable. There is no placebo group, and each subject wil be his or her own control. Receives: Device: Truview PCD |
| Glidescope Cobolt | Active comparator | Subjects were required to watch a instructional video provided by the manufacterer. Subjects were then allowed to practice on a normal model until they felt comfortable before beginning the study. There is no placebo group, and each subject wil be his or her own control. Receives: Device: Glidescope Cobolt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required for successful endotracheal intubation with the three devices.
The devices to be compared include (1)the standard Miller blade, (2) the GlideScope Cobalt AVL and (3) the Truview PCD video-laryngoscopes. Successful intubation will be measured in the seconds from the time the recorder says "begin" until time of first positive pressure breath and confirmation endotracheal tube is in the trachea.
Measured: Subjects complete study in 1 day
Secondary outcomes (7)
Time to visualize the larynx
Start time is when the recorder says "begin" . The time to visualize the larynx ends when the subject rates best view of the larynx.
Measured: From time recorder says "begin" till subject rates best view up to 3minutes
Time from visualization of larynx to tracheal intubation
time from the beginning of the endotracheal tube being inserted till first positive pressure breath measured in seconds.
Measured: one day
Number of attempts at tracheal intubation
Subjects were allowed a total of 3 attempts at tracheal intubation with a device on a mannequin.
Measured: one day
Number of failed attempts
Subjects were allowed 3 unsuccessful attempts with each device. After 3 unsuccessful attempts with a device the subject was considered to have failed that device.
Measured: one day
Amount of force on the maxilla
Observer rated the amount of force on the maxilla based on a 0-10 point scale. The observer was the same for all cases.
Measured: one day
Optimization measures for laryngeal visualization and tracheal intubation
The subjects were allowed to ask for assistance with optimization such as external tracheal pressure, lip retraction, or pulling on the tongue. All subjects were instructed that no measures would be taken unless asked for and intructed on what assistance was needed. The observer recorded and counted all optimizing measures.
Measured: one day
Documentation of participant's comments on preference of device
All participants were asked at the completion of the study what device they prefered for a case with anticipated difficult intubation. A count was made of their preference.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startJun 2013
- Primary completionNov 2014
- Study completionDec 2014
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 Baylor College of MedicineThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Karlberg, Baylor College of Medicine
- Investigators
- Helena Karlberg, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198742
- Sponsor's protocol ID
- H28224
- Status last verified
- Feb 2015
- First submitted
- 15 Jan 2014
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Two Video Laryngoscopes,the Truview PCD and the Glidescope Cobalt AVL, in Successfully Intubating Pediatric Mannequins With and Without Difficult Airways
- ClinicalTrials.gov ID
- NCT02198742
- Acronym / sponsor ID
- H28224
- Conditions
- Intubation; Difficult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Jul 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.
The study is a randomized crossover study where anesthesia practitioners will intubate three different pediatric infant mannequins (normal airway, anterior larynx, Pierre Robin syndrome anatomy) using three different intubation devices (the Miller blade, the Truview VL, the Glidescope Cobalt video-laryngoscope) in two different scenarios (normal neck and with an immobile neck). The order of presentation will be randomized. As this is a cross over study, all subjects will complete all scenarios. There is no placebo group, and each subject wil be his or her own control.
Detailed description
Participants will be given individual, standardized instructions and demonstrations for each device as per the manufacturers' instructions. The participants will practice with instructor's feedback on an infant mannequin with a normal airway until he/she feel comfortable with each of the three devices. The investigator will record the prior experience of the participant in using each of the 3 devices in clinical situations. Each subject will be asked to intubate each of the mannequins with each of the devices. The choice of the order of device and mannequin will be based on a Latin square design and the sequence will be assigned to participants based on a computer generated random number. A closed envelope technique will blind participants and investigators to the order of airway device and mannequin till the start of the individual trial. Participants will first finish the test on unchanged conditions and then repeat the process using the same order of mannequins and devices but with the neck held immobile to simulate a scenario of a child with an unstable cervical spine. Data from different scenarios will be recorded from a total number of 18 attempts of tracheal intubation per participant. Participants will be asked to proceed as though they were in the operating room with an assistant available to follow their commands. The order of presentation of each mannequin, airway device and scenario will be randomized as described above. The time from placing the device in the mannequin's mouth to the time the Ambu bag is connected to the end of the tracheal tube and a positive pressure breath is given will constitute the intubation time. During each intubation the participant will be asked to state when he or she has obtained the best view for intubation and this time this will be recorded as the time for visualization. The subject will assess the quality of the best glottic view on the Cormack - Lehane grade of 1 -4. The investigators will record all maneuvers to optimize visualization of the larynx such as tracheal pressure, lip retraction, pulling the tongue forward etc. The time from entry of the device in the mouth to the time the tracheal tube is started to be advanced is the visualization time. The time a positive pressure breath is given at the end of the tracheal tube will constitute the end of the attempt of intubation. A failed attempt is defined as removal of the laryngoscope from the mouth without a successful intubation. The number of times the endotracheal tube is advanced will also be recorded. Failure of intubation will be defined as unrecognized esophageal intubation, abandoned procedure, intubation taking longer than 120 seconds and intubation requiring more than 3 attempts. The observer will estimate the maximum force applied to the maxilla on a 0 -10 scale where 0= no force and 10 = maximum force with distortion of the maxilla. The observer will also estimate potential damage of laryngeal structures on a 0 -10 scale.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Miller blade | Active comparator | Device: Miller bladeSubjects must have >500 intubations in order to participate in this study. There is no placebo group, and each subject wil be his or her own control. |
| Truview PCD | Active comparator | Device: Truview PCDSubjects were given a quick guide of the Truview PCD supplied by the manufacturer with step by step instructions for use. They were also given time to practice with the device on a normal model until they felt comfortable. There is no placebo group, and each subject wil be his or her own control. |
| Glidescope Cobolt | Active comparator | Device: Glidescope CoboltSubjects were required to watch a instructional video provided by the manufacterer. Subjects were then allowed to practice on a normal model until they felt comfortable before beginning the study. There is no placebo group, and each subject wil be his or her own control. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Anesthesia practitioners including anesthesia attendings, fellows, residents CAIII and CRNA's at Texas Children's Hospital Department of Anesthesiology with clinical experience of >500 intubations with Miller blades.
Key exclusion criteria (1 listed)
- Anesthesia practitioners with <500 intubations with Miller blades.
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 |
|---|---|---|
| Miller bladeTo participate in the study the subjects must have >500 intubations with the miller blade. | Device | Miller blade |
| Truview PCDAlso: Trueview PCD - Multichoice video laryngoscope systemSubjects were given a quick guide of the Truview PCD supplied by the manufacturer with step by step instructions for use. They were also given time to practice with the device on a normal model until they felt comfortable. | Device | Truview PCD |
| Glidescope CoboltSubjects were required to watch a instructional video provided by the manufacturer. Subjects were then allowed to practice on a normal model until they felt comfortable before beginning the study. There is no placebo group, and each subject wil be his or her own control. | Device | Glidescope Cobolt |
Primary outcome
Time required for successful endotracheal intubation with the three devices.
Time frame: Subjects complete study in 1 day
The devices to be compared include (1)the standard Miller blade, (2) the GlideScope Cobalt AVL and (3) the Truview PCD video-laryngoscopes. Successful intubation will be measured in the seconds from the time the recorder says "begin" until time of first positive pressure breath and confirmation endotracheal tube is in the trachea.
7 secondary outcomes
Time to visualize the larynx
Time frame: From time recorder says "begin" till subject rates best view up to 3minutes
Time from visualization of larynx to tracheal intubation
Time frame: one day
Number of attempts at tracheal intubation
Time frame: one day
Number of failed attempts
Time frame: one day
Amount of force on the maxilla
Time frame: one day
Optimization measures for laryngeal visualization and tracheal intubation
Time frame: one day
Documentation of participant's comments on preference of device
Time frame: one day
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 3 Feb 2015.
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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.
Helena Karlberg, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Miller blade, Truview PCD and Glidescope Cobolt in people with Intubation; Difficult, run by Baylor College of Medicine 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 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: finished, as of the sponsor's last update on 3 Feb 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 required for successful endotracheal intubation with the three devices. (time frame: Subjects complete study in 1 day). 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 3 Feb 2015.