IntubationNCT01023568
Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients
A study testing Macintosh blade, Glidescope and Truview PCD in people with Intubation, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of two novel videolaryngoscope systems, the Glidescope and the Truview PCD against standard direct laryngoscopy (DL) in pediatric patients. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Intubation
- What is being tested?
- Macintosh blade, Glidescope and Truview PCD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to May 2011
- 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 Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status I-III
- elective general surgical procedures
- from 0-10 years-old
Who cannot join
- increase intracranial pressure
- history of severe gastrointestinal reflux
- sore throat
- upper respiratory airway infection
- known or suspected difficult airway or coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the effectiveness of two novel videolaryngoscope systems, the Glidescope and the Truview PCD against standard direct laryngoscopy (DL) in pediatric patients. The investigators primary hypothesis is that the use of videolaryngoscope devices, Glidescope and Truview provide better laryngeal views in pediatric patients as measured by Cormack and ehane (C\&L) (1 to 4, 4 the worst), without increasing the time taken to intubate (TTI), compared with direct laryngoscopy (DL).
The investigators secondary hypotheses are that the use of Glidescope and Truview PCD provoke less hemodynamic response and fewer episodes of de-saturation in pediatric patients.
Read the detailed description
Advances in airway management have led to development on videolaryngoscopy devices including the Glidescope® (Verathon Inc, Bothwell, USA), the AWD® (Pentax Corporation, Tokio, Japan) and most recently the Truview PCD (Truphatek International Ltd, Netanya, Israel). The use of videolaryngoscopy devices in adults have demonstrated some advantages including, minimal trauma on the airway and better view of the glottis.
The Glidescope is designed with a 60º angle and a camera on the inferior aspect just at the inflection point. The view is obtained anteriorly and the camera is located remote from the glottis providing a good visual field. The video image is displayed on a Liquid Crystal Display (LCD), with electronic recording available. Despite a good experience using Glidescope in adults, few studies have been published in pediatric patients. Kim et al. in a randomized study comparing the use of Glidescope with direct laryngoscopy in children, demonstrated better or equal laryngoscopic view with longer time for intubation using the Glidescope.
- Conditions
- Intubation
- Being tested
- Macintosh blade, Glidescope, Truview PCD
- Keywords
- intubation, pediatric, videolaryngoscope devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh bladeDevice
Intubation with Macintosh blade laryngoscope
GlidescopeDevice
Intubation with Glidescope laryngoscope.
Truview PCDDevice
Intubation with Truview PCD laryngoscope.
| Study group | Role | What they receive |
|---|---|---|
| Macintosh blade | Active comparator | Intubation with Macintosh blade laryngoscope Receives: Device: Macintosh blade |
| Glidescope | Active comparator | Intubation with Glidescope laryngoscope Receives: Device: Glidescope |
| Truview PCD | Active comparator | Intubation with the Truview PCD laryngoscope Receives: Device: Truview PCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Successfully Intubate Patient.
Measured: from start of intubation to successfully intubated up to 5 minutes
Secondary outcomes (4)
Mean Hemodynamic Response: Mean Arterial Blood Pressure
Measured: measured at 1 minute interval at induction time and from intubation for 10 minutes
Cormack-Lehane Grade
Measured: immediately after intubation
Mean Hemodynamic Response: Heart Rate
Measured: measured at 1 minute interval at induction time and from intubation for 10 minutes.
Number of Participants Who Experienced Desaturation
Desaturation was defined as SpO2 less than 90% at induction time or any time from intubation to 10 minutes after
Measured: measured at 1 minute interval at induction time and from intubation for 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: The study was stopped for futility at the first interim analysis
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 IntubationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Niezgoda, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023568
- Sponsor's protocol ID
- 09-902
- Status last verified
- Dec 2016
- First submitted
- 1 Dec 2009
- Last updated
- 2 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01023568
- Acronym / sponsor ID
- 09-902
- Conditions
- Intubation
- Keywords
- intubation, pediatric, videolaryngoscope devices
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped for futility at the first interim analysis
- Enrolment
- 134 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Posted 2 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of two novel videolaryngoscope systems, the Glidescope and the Truview PCD against standard direct laryngoscopy (DL) in pediatric patients. The investigators primary hypothesis is that the use of videolaryngoscope devices, Glidescope and Truview provide better laryngeal views in pediatric patients as measured by Cormack and ehane (C\&L) (1 to 4, 4 the worst), without increasing the time taken to intubate (TTI), compared with direct laryngoscopy (DL).
The investigators secondary hypotheses are that the use of Glidescope and Truview PCD provoke less hemodynamic response and fewer episodes of de-saturation in pediatric patients.
Detailed description
Advances in airway management have led to development on videolaryngoscopy devices including the Glidescope® (Verathon Inc, Bothwell, USA), the AWD® (Pentax Corporation, Tokio, Japan) and most recently the Truview PCD (Truphatek International Ltd, Netanya, Israel). The use of videolaryngoscopy devices in adults have demonstrated some advantages including, minimal trauma on the airway and better view of the glottis.
The Glidescope is designed with a 60º angle and a camera on the inferior aspect just at the inflection point. The view is obtained anteriorly and the camera is located remote from the glottis providing a good visual field. The video image is displayed on a Liquid Crystal Display (LCD), with electronic recording available. Despite a good experience using Glidescope in adults, few studies have been published in pediatric patients. Kim et al. in a randomized study comparing the use of Glidescope with direct laryngoscopy in children, demonstrated better or equal laryngoscopic view with longer time for intubation using the Glidescope.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Macintosh blade | Active comparator | Device: Macintosh bladeIntubation with Macintosh blade laryngoscope |
| Glidescope | Active comparator | Device: GlidescopeIntubation with Glidescope laryngoscope |
| Truview PCD | Active comparator | Device: Truview PCDIntubation with the Truview PCD laryngoscope |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA physical status I-III
- elective general surgical procedures
- from 0-10 years-old
Key exclusion criteria (5 listed)
- increase intracranial pressure
- history of severe gastrointestinal reflux
- sore throat
- upper respiratory airway infection
- known or suspected difficult airway or coagulopathy
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 |
|---|---|---|
| Macintosh bladeIntubation with Macintosh blade laryngoscope | Device | Macintosh blade |
| GlidescopeIntubation with Glidescope laryngoscope. | Device | Glidescope |
| Truview PCDIntubation with Truview PCD laryngoscope. | Device | Truview PCD |
Primary outcome
Time to Successfully Intubate Patient.
Time frame: from start of intubation to successfully intubated up to 5 minutes
4 secondary outcomes
Mean Hemodynamic Response: Mean Arterial Blood Pressure
Time frame: measured at 1 minute interval at induction time and from intubation for 10 minutes
Cormack-Lehane Grade
Time frame: immediately after intubation
Mean Hemodynamic Response: Heart Rate
Time frame: measured at 1 minute interval at induction time and from intubation for 10 minutes.
Number of Participants Who Experienced Desaturation
Time frame: measured at 1 minute interval at induction time and from intubation for 10 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Julie Niezgoda, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh blade, Glidescope and Truview PCD in people with Intubation, run by The Cleveland Clinic 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 2 Feb 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 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 2 Feb 2017). 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 Successfully Intubate Patient. (time frame: from start of intubation to successfully intubated up to 5 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 2 Feb 2017.