Percent of Glottic OpeningNCT01717872
Comparing the Laryngoscopy View Using Miller and Macintosh Laryngoscopy Blades in Infants Under Two Years of Age
A study testing Laryngoscope blade in people with Percent of Glottic Opening, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
To compare the laryngoscopy view using two standard clinical devices, the Macintosh and Miller laryngoscopy blades, in infants between one day and two years of age. Miller blades (straight blades) are more commonly used than MacIntosh blades (curved) in pediatric clinical practice in some institutions especially in… Read more about this study
- Who is it for?
- Ages 1 day to 2 years
- Conditions the study is for
- Percent of Glottic Opening
- What is being tested?
- Laryngoscope blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jul 2013
- 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 1 day to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American society of anesthesiologists physical status 1 and 2 infants and children
- Age <2 years of age
- All racial and ethnic origin
- Scheduled for elective surgery
- Fasting patients who are unmedicated preoperatively
Who cannot join
- History of difficult airway
- Severe asthma
- Premature birth
- ICU stay for more than a week following delivery
- Acute or chronic pulmonary or neuromuscular diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Childrens Hospital of Buffalo
Buffalo, New York, 14222
About this study
To compare the laryngoscopy view using two standard clinical devices, the Macintosh and Miller laryngoscopy blades, in infants between one day and two years of age.
Miller blades (straight blades) are more commonly used than MacIntosh blades (curved) in pediatric clinical practice in some institutions especially in infants. The anatomy of infant airway has traditionally been considered to lend itself to advantages of the Miller blade. Some argue that the Miller blade offers a superior view of the laryngeal inlet because it lifts the epiglottis. However, others use the Miller blade to expose the larynx without lifting the epiglottis, supposedly to avoid traumatizing it. Despite the long-standing use of these blades, more than 50 years, no systematic study has ever compared the laryngoscopy views of the Miller and Macintosh blades in infants.
Read the detailed description
- After Institutional Review Board approval, the patients meeting inclusion criteria will be selected from the Operating room elective surgical list.
- They will be randomized to one of the two groups: a #1 Miller or Macintosh blade.
- After obtaining informed consent from the parent or the legal guardian, monitors (electrocardiogram, non-invasive blood pressure monitor and pulse oximeter) that are routine induction of anesthesia will be applied and anesthesia will be induced using an inhalation technique with sevoflurane, nitrous oxide and oxygen. An intravenous cannula will then be placed. The child will then receive a standard intubating dose of a muscle relaxant (rocuronium 0.5-1 mg/kg). The lungs will be mask ventilated using 100% oxygen in Sevoflurane for 3 minutes to allow appropriate time for the muscle relaxant to be fully effective. At that time, the randomized code for that child will be opened and laryngoscopy will be performed with either a Miller or MacIntosh blade as indicated by the code.
- The best possible glottic view will be obtained by ensuring the following steps. The child's head will be positioned in the Magill position, muscle relaxant will be administered, firm forward traction will be applied to the laryngoscope handle, and if needed, external laryngeal manipulation will be applied.
- During the same laryngoscopy, the best glottic visualization will be obtained with the blade lifting the epiglottis and not lifting the epiglottis, in random order (by flipping a coin). This difference is a matter of moving the position of the blade back without removing the blade from the larynx.
- The two views will be recorded by a second doctor using a SONY camera at the mouth adjacent to the laryngoscope handle.
- Photos of the glottic opening will be graded using the POGO scale (Ref1) by a third (blinded) anesthesiologist.
- All of the intubations and image acquisition will be performed by Drs. Yuvesh Passi, Jerrold Lerman or Chris Heard.
- The images obtained will not have patient identifiers included. They will be stored in a secure file once the study is completed that will be accessed only by investigators involved in the study.
- No patient identifiers will be included on any documentation apart from the source documents.
- The research data will be stored in a locked office of Dr. Lerman (Room 251) in Department of Anesthesia, Women and Children's Hospital of Buffalo during and after the study for security to protect subject privacy and confidentiality.
- There will be no payments or compensation to the study subjects
The primary hypothesis of this study is to compare the view of the larynx with Miller blade while lifting the epiglottis to the Macintosh blade lifting the tongue, in infants and children <2 years of age. However, views will be obtained with the Miller and Macintosh blades both lifting and not lifting the epiglottis and comparisons between pairs of measurements will be performed. In order for to detect superiority of one technique over the other, we will need a difference in the POGO scores of 25 points with a standard deviation of 25 points, yielding a sample size of 15 children in each group. To account for photographic difficulties, unreadable photos as well as dropouts, we will enroll 25 children in each group. Therefore a total of 50 children will be enrolled.
- Conditions
- Percent of Glottic Opening
- Being tested
- Laryngoscope blade
- Keywords
- glottis, laryngoscopy, laryngoscope blade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngoscope bladeDevice
Also called Macintosh laryngoscope blade, Miller laryngoscope blade
The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades lifting and not lifting the epiglotis
| Study group | Role | What they receive |
|---|---|---|
| Macintosh laryngoscope blade | Active comparator | A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the Percent of Glottic Opening (POGO) score by a blinded assessor. Receives: Device: Laryngoscope blade |
| Miller laryngoscope blade | Active comparator | A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the percent of glottic opening score by a blinded assessor. Receives: Device: Laryngoscope blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
The View of the Larynx (Glottis Opening) as Determined by POGO Score (Percentage of Glottic Opening).
Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the Macintosh blade lifting the tongue
Measured: 30 seconds
Secondary outcomes (2)
Percent of Glottic Opening With the Miller Blade Lifting the Epiglottis and Tongue
Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the same blade lifting the tongue
Measured: 30 seconds
Percent of Glottic Opening With the MAC Blade Lifting the Tongue and the Epiglottis
The MAC blade was inserted under the tongue to view the percent glottic opening and compared with the view with the same blade lifting the epiglottis to view the percent glottic opening.
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionJul 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percent of Glottic OpeningStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerrold Lerman, State University of New York at Buffalo
- Investigators
- Jerrold Lerman, MD, Principal investigator, SUNY at Buffalo, Women and Children's Hospital of Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717872
- Sponsor's protocol ID
- Lerman Blade study
- Status last verified
- Feb 2017
- First submitted
- 28 Oct 2012
- Last updated
- 20 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Passi Y, Sathyamoorthy M, Lerman J, Heard C, Marino M. Comparison of the laryngoscopy views with the size 1 Miller and Macintosh laryngoscope blades lifting the epiglottis or the base of the tongue in infants and children <2 yr of age. Br J Anaesth. 2014 Nov;113(5):869-74. doi: 10.1093/bja/aeu228. Epub 2014 Jul 25.
PubMed 25062740
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Laryngoscopy View Using Miller and Macintosh Laryngoscopy Blades in Infants Under Two Years of Age
- ClinicalTrials.gov ID
- NCT01717872
- Acronym / sponsor ID
- Lerman Blade study
- Conditions
- Percent of Glottic Opening
- Keywords
- glottis, laryngoscopy, laryngoscope blade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Posted 11 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the laryngoscopy view using two standard clinical devices, the Macintosh and Miller laryngoscopy blades, in infants between one day and two years of age.
Miller blades (straight blades) are more commonly used than MacIntosh blades (curved) in pediatric clinical practice in some institutions especially in infants. The anatomy of infant airway has traditionally been considered to lend itself to advantages of the Miller blade. Some argue that the Miller blade offers a superior view of the laryngeal inlet because it lifts the epiglottis. However, others use the Miller blade to expose the larynx without lifting the epiglottis, supposedly to avoid traumatizing it. Despite the long-standing use of these blades, more than 50 years, no systematic study has ever compared the laryngoscopy views of the Miller and Macintosh blades in infants.
Detailed description
- After Institutional Review Board approval, the patients meeting inclusion criteria will be selected from the Operating room elective surgical list.
- They will be randomized to one of the two groups: a #1 Miller or Macintosh blade.
- After obtaining informed consent from the parent or the legal guardian, monitors (electrocardiogram, non-invasive blood pressure monitor and pulse oximeter) that are routine induction of anesthesia will be applied and anesthesia will be induced using an inhalation technique with sevoflurane, nitrous oxide and oxygen. An intravenous cannula will then be placed. The child will then receive a standard intubating dose of a muscle relaxant (rocuronium 0.5-1 mg/kg). The lungs will be mask ventilated using 100% oxygen in Sevoflurane for 3 minutes to allow appropriate time for the muscle relaxant to be fully effective. At that time, the randomized code for that child will be opened and laryngoscopy will be performed with either a Miller or MacIntosh blade as indicated by the code.
- The best possible glottic view will be obtained by ensuring the following steps. The child's head will be positioned in the Magill position, muscle relaxant will be administered, firm forward traction will be applied to the laryngoscope handle, and if needed, external laryngeal manipulation will be applied.
- During the same laryngoscopy, the best glottic visualization will be obtained with the blade lifting the epiglottis and not lifting the epiglottis, in random order (by flipping a coin). This difference is a matter of moving the position of the blade back without removing the blade from the larynx.
- The two views will be recorded by a second doctor using a SONY camera at the mouth adjacent to the laryngoscope handle.
- Photos of the glottic opening will be graded using the POGO scale (Ref1) by a third (blinded) anesthesiologist.
- All of the intubations and image acquisition will be performed by Drs. Yuvesh Passi, Jerrold Lerman or Chris Heard.
- The images obtained will not have patient identifiers included. They will be stored in a secure file once the study is completed that will be accessed only by investigators involved in the study.
- No patient identifiers will be included on any documentation apart from the source documents.
- The research data will be stored in a locked office of Dr. Lerman (Room 251) in Department of Anesthesia, Women and Children's Hospital of Buffalo during and after the study for security to protect subject privacy and confidentiality.
- There will be no payments or compensation to the study subjects
The primary hypothesis of this study is to compare the view of the larynx with Miller blade while lifting the epiglottis to the Macintosh blade lifting the tongue, in infants and children <2 years of age. However, views will be obtained with the Miller and Macintosh blades both lifting and not lifting the epiglottis and comparisons between pairs of measurements will be performed. In order for to detect superiority of one technique over the other, we will need a difference in the POGO scores of 25 points with a standard deviation of 25 points, yielding a sample size of 15 children in each group. To account for photographic difficulties, unreadable photos as well as dropouts, we will enroll 25 children in each group. Therefore a total of 50 children will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macintosh laryngoscope blade | Active comparator | Device: Laryngoscope bladeA photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the Percent of Glottic Opening (POGO) score by a blinded assessor. |
| Miller laryngoscope blade | Active comparator | Device: Laryngoscope bladeA photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the percent of glottic opening score by a blinded assessor. |
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- American society of anesthesiologists physical status 1 and 2 infants and children
- Age <2 years of age
- All racial and ethnic origin
- Scheduled for elective surgery
- Fasting patients who are unmedicated preoperatively
Key exclusion criteria (5 listed)
- History of difficult airway
- Severe asthma
- Premature birth
- ICU stay for more than a week following delivery
- Acute or chronic pulmonary or neuromuscular diseases
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 |
|---|---|---|
| Laryngoscope bladeAlso: Macintosh laryngoscope blade, Miller laryngoscope bladeThe POGO score will be used to assess the percent of the glottis that can be seen with each of the blades lifting and not lifting the epiglotis | Device | Macintosh laryngoscope blade, Miller laryngoscope blade |
Primary outcome
The View of the Larynx (Glottis Opening) as Determined by POGO Score (Percentage of Glottic Opening).
Time frame: 30 seconds
Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the Macintosh blade lifting the tongue
2 secondary outcomes
Percent of Glottic Opening With the Miller Blade Lifting the Epiglottis and Tongue
Time frame: 30 seconds
Percent of Glottic Opening With the MAC Blade Lifting the Tongue and the Epiglottis
Time frame: 30 seconds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25062740Passi Y, Sathyamoorthy M, Lerman J, Heard C, Marino M. Comparison of the laryngoscopy views with the size 1 Miller and Macintosh laryngoscope blades lifting the epiglottis or the base of the tongue in infants and children <2 yr of age. Br J Anaesth. 2014 Nov;113(5):869-74. doi: 10.1093/bja/aeu228. Epub 2014 Jul 25.
- Individual participant dataSharing planned: No
Related trials for Percent of Glottic Opening
Not yet recruitingObservational study
Effect Of Left Head Rotation On Glottic View During Video Laryngoscopy In Obese Adults
Difficult Airway, Obesity Difficult Airway Airway Management
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.
Jerrold Lerman, MD principal investigator
SUNY at Buffalo, Women and Children's Hospital of Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngoscope blade in people with Percent of Glottic Opening, run by State University of New York at Buffalo 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 5 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: finished, as of the sponsor's last update on 20 Mar 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 11 Apr 2016). 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?
The View of the Larynx (Glottis Opening) as Determined by POGO Score (Percentage of Glottic Opening). (time frame: 30 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01717872, which also lists 1 linked publication.
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 20 Mar 2017.