LaryngoscopyTruviewNCT00803751
A Comparison of the Infant Truview EVO2 Video Laryngoscope and the Macintosh Laryngoscope in Pediatric Patients
A study testing Truview EVO2 laryngoscope and Macintosh laryngoscope in people with Laryngoscopy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This study is intended to examine the effectiveness of a new type of laryngoscope, the Truview EVO2, in an infant patient population. They device will be tested against the current clinical standard, the Macintosh laryngoscope, in patients undergoing surgery at our hospital in terms of ease of use, view obtained of… Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Laryngoscopy
- What is being tested?
- Truview EVO2 laryngoscope and Macintosh laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Dec 2009
- 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 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age less than one year
- Requiring general anesthesia and orotracheal intubation
- Weight less than 10 kg
- ASA class 1-3
Who cannot join
- Documented difficult airway
- Facial deformities
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, 77030
About this study
This study is intended to examine the effectiveness of a new type of laryngoscope, the Truview EVO2, in an infant patient population. They device will be tested against the current clinical standard, the Macintosh laryngoscope, in patients undergoing surgery at our hospital in terms of ease of use, view obtained of the vocal cords, and ability to place an endotracheal tube.
- Conditions
- Laryngoscopy
- Being tested
- Truview EVO2 laryngoscope, Macintosh laryngoscope
- Keywords
- Laryngoscopy [E04.580.373]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Truview EVO2 laryngoscopeDevice
will use the Truview laryngoscope instead of the traditional Macintosh laryngoscope
Macintosh laryngoscopeDevice
Intubation using the traditional Macintosh laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Truview intubation | Experimental | Receive laryngoscopy with Truview first and is immediately followed by laryngoscopy and intubation with Macintosh Receives: Device: Truview EVO2 laryngoscope |
| Macintosh intubation | Active comparator | Macintosh blade will be used first followed by laryngoscopy and intubation with the truview Receives: Device: Macintosh laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Laryngeal View Obtained on Comarck Lehane Classification
The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.
Measured: during laryngoscopy prior to intubation. Few minutes before intubation
Number of Intubation Attempts
Number of participants with the indicated number of intubation attempts (1/2/3)
Measured: during intubation prior to surgery
Quality of Laryngeal View Obtained With 2nd Laryngoscopy
The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.
Measured: during laryngoscopy prior to intubation (few minutes prior to intubation)
Secondary outcomes (3)
Time Taken for Intubation
Measured: throughout the intubation procedure
POGO Score With 1st Laryngoscopy
POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening.
Measured: Before patient is intubated (few minutes before intubation)
POGO Score With 2nd Laryngoscopy
POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening.
Measured: Before patient is intubated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2009
- Study completionDec 2009
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 LaryngoscopyStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Matuszczak, The University of Texas Health Science Center, Houston
- Investigators
- Maria Matuszczak, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803751
- Sponsor's protocol ID
- Infant Truview
- Acronym
- Truview
- Status last verified
- Mar 2011
- First submitted
- 5 Dec 2008
- Last updated
- 15 May 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 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Infant Truview EVO2 Video Laryngoscope and the Macintosh Laryngoscope in Pediatric Patients
- ClinicalTrials.gov ID
- NCT00803751
- Acronym / sponsor ID
- Truview / Infant Truview
- Conditions
- Laryngoscopy
- Keywords
- Laryngoscopy [E04.580.373]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Dec 2008 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to examine the effectiveness of a new type of laryngoscope, the Truview EVO2, in an infant patient population. They device will be tested against the current clinical standard, the Macintosh laryngoscope, in patients undergoing surgery at our hospital in terms of ease of use, view obtained of the vocal cords, and ability to place an endotracheal tube.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Truview intubation | Experimental | Device: Truview EVO2 laryngoscopeReceive laryngoscopy with Truview first and is immediately followed by laryngoscopy and intubation with Macintosh |
| Macintosh intubation | Active comparator | Device: Macintosh laryngoscopeMacintosh blade will be used first followed by laryngoscopy and intubation with the truview |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age less than one year
- Requiring general anesthesia and orotracheal intubation
- Weight less than 10 kg
- ASA class 1-3
Key exclusion criteria (2 listed)
- Documented difficult airway
- Facial deformities
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 |
|---|---|---|
| Truview EVO2 laryngoscopewill use the Truview laryngoscope instead of the traditional Macintosh laryngoscope | Device | Truview intubation |
| Macintosh laryngoscopeIntubation using the traditional Macintosh laryngoscope | Device | Macintosh intubation |
Primary outcome
Quality of Laryngeal View Obtained on Comarck Lehane Classification
Time frame: during laryngoscopy prior to intubation. Few minutes before intubation
The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.
Number of Intubation Attempts
Time frame: during intubation prior to surgery
Number of participants with the indicated number of intubation attempts (1/2/3)
Quality of Laryngeal View Obtained With 2nd Laryngoscopy
Time frame: during laryngoscopy prior to intubation (few minutes prior to intubation)
The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.
3 secondary outcomes
Time Taken for Intubation
Time frame: throughout the intubation procedure
POGO Score With 1st Laryngoscopy
Time frame: Before patient is intubated (few minutes before intubation)
POGO Score With 2nd Laryngoscopy
Time frame: Before patient is intubated
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Truphatek - Manufacturer's websiteLink provided by the sponsor.
Related trials for Laryngoscopy
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Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
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Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
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LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
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Recruiting
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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.
Maria Matuszczak, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Truview EVO2 laryngoscope and Macintosh laryngoscope in people with Laryngoscopy, run by The University of Texas Health Science Center, Houston 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 2 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 May 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 15 May 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?
Quality of Laryngeal View Obtained on Comarck Lehane Classification (time frame: during laryngoscopy prior to intubation. Few minutes before intubation). The study lists 3 primary outcomes in all. 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 May 2017.