NewbornNCT03112798
Miller vs Macintosh Size 0 Blades for Tracheal Intubation of Infants
An observational study of Newborn, run by Istanbul Science University.
Trial summary
Miller blades are commonly used in pediatric anesthesia; however, there is less evidence-based information on the superiority of Miller blades in the visualization of the laryngeal inlet to Macintosh blades. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Newborn
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to 1 Dec 2017
- How long will I take part?
- 4 Months
- Phase
- Observational
- 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 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Study population: The study population will include newborns
Who may be able to join
- ASA I or II patients under 1 month.
Who cannot join
- Infants with a history of a difficult airway or diagnosed congenital syndrome, premature infants less than 37 weeks gestational age at birth, and those with acute or chronic pulmonary or neuromuscular diseases will be excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Miller vs Macintosh Size 0 Blades for Tracheal Intubation of Infants Under 1 Month: a Randomized Comparative Study
Miller blades are commonly used in pediatric anesthesia; however, there is less evidence-based information on the superiority of Miller blades in the visualization of the laryngeal inlet to Macintosh blades. The aim of the present study is to compare the glottic views with the size 0 Macintosh and Miller laryngoscope blades above and below the epiglottis.
Read the detailed description
Miller blades are commonly used in pediatric anesthesia; however, there is less evidence-based information on the superiority of Miller blades in the visualization of the laryngeal inlet to Macintosh blades (1,2). Therefore prospective randomized comparative studies on this field is required. Passi et al. (3) have demonstrated that, in 50 children aged between 6 months and 2 years, optimal laryngeal views could be obtained with either the Miller size 1 blades lifting the epiglottis or with Macintosh size 1 blades lifting the tongue base. Another clinical trial compared the laryngoscopic views and tracheal intubation conditions with Macintosh and Miller blades in children from 1 month to 24 months. In this study involving 120 children, similar glottic views were obtained with both blades in 43% of the children while a better view was observed with the Miller blade in 29% of the children and with the Macintosh blade in 28% (4). Direct laryngoscopy for tracheal intubation in neonates is a procedure that mostly requires experience and constant practice (5). Neonates have a number of distinctive airway characteristics. These characteristics include the large tongue and head, the floppy, narrow U-shaped epiglottis, the larynx that is located more cephalad, and the vocal cords that are angled in an anterior-caudal position (4). Therefore, straight laryngoscope blades are recommended for use in children and infants under 2 years of age.
In neonatal tracheal intubations, Miller blade is the most frequently utilized blade (6). The reasons for this include the effective displacement of the tongue to the left of the laryngoscope with the Miller blade and the effective lifting of the long and floppy epiglottis during laryngoscopy (3). However, there is no prospective randomized and blinded comparative clinical study on this subject. The aim of the present study is to compare the glottic views with the size 0 Macintosh and Miller laryngoscope blades above and below the epiglottis.
Methods:
For the present study, the Ethics Committee approval was be obtained from the Faculty of Medicine, Istanbul Science University. Written informed consent will be obtained from the parents of patients undergoing elective surgery. The study will involve ASA I or II patients under 1 month. Infants with a history of a difficult airway or diagnosed congenital syndrome, premature infants less than 37 weeks gestational age at birth, and those with acute or chronic pulmonary or neuromuscular diseases will be excluded from the study. Twenty five children undergoing elective surgery will be enrolled in the study. Infants will be randomized (using www.random.com) into two groups, the Miller and Macintosh blade groups, and whether the assigned blade is inserted above or below the epiglottis first, with allocation stored within sealed opaque envelopes until consent is obtained.
In a standard monitoring process, electrocardiogram (ECG), oxygen saturation, non-invasive blood pressure (NIBP), temperature and end-tidal CO2 pressure (EtCO2) will be monitored. Following the monitoring, anesthesia will be induced with 50% air, 50% oxygen and 8% sevoflurane. Once intravenous access is obtained, 0.5 mg/kg rocuronium will be administered. After preoxygenating with 100% oxygen and sevoflurane for 3 minutes, the assigned blade will be inserted into the mouth. All laryngoscopies will be performed by one of three paediatric anesthetists. The Miller blade will be inserted into the mouth at the right commissure and the tongue swept gently to the left. The best laryngeal view will be achieved by optimizing the head position and applying external pressure to the larynx. As described by Passi et al. (3), two laryngeal views will be obtained with the same blade in each patient: lifting the epiglottis or the tongue base. The order of the views (lifting the epiglottis or the tongue base) will be determined by randomization immediately before laryngoscopy. The laryngeal views will be photographed each time by an anesthetist using a digital Olympus camera without using flash. The camera will be optimally positioned before laryngoscopy in order to capture the best possible views. The photos will be reviewed by a blinded anesthetist using the percentage of glottic opening (POGO) score (7,8). This anesthetist will be blinded to the study hypothesis as well as which blade was used and where it was placed. We will photo the child's name and the randomization code-blade type and which view was taken before and after each photo of the larynx. Then the photos will be uploaded and the number of the photo will be recorded in the study record for the child so we will know which photo corresponds to which blade and position for each child. After all the photos are taken, they will be randomized and given to the blinded observer to measure the vocal cord span.
- Conditions
- Newborn
- Keywords
- tracheal intubation, Macintosh blade, Miller blade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Macintosh group | The patients will be intubated by using Macintosh blades and the outcomes will be compared with Miller blades. | |
| Miller group | The patients will be intubated by using Miller blades and the outcomes will be compared with Macintosh blades. |
What is being measured
The primary outcome is the main question the study is designed to answer.
POGO scores
the laryngeal views will be photographed during laryngoscopy and will be compared
Measured: five months
Secondary outcomes (1)
complications
any complication will be recorded during tracheal intubation with each device
Measured: five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start1 May 2017 (estimated)
- Primary completion1 Nov 2017 (estimated)
- Study completion1 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for NewbornStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Istanbul Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemal Tolga Saracoglu, Istanbul Science University
- Investigators
- Kemal T Saracoglu, Principal investigator, Istanbul Science University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112798
- Sponsor's protocol ID
- 44140529/2016-50
- Status last verified
- Apr 2017
- First submitted
- 23 Mar 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
DAVENPORT HT, ROSALES JK. Endotracheal intubation of infants and children. Can Anaesth Soc J. 1959 Jan;6(1):65-74. doi: 10.1007/BF03014197. No abstract available.
PubMed 13608313Jones RM, Jones PL, Gildersleve CD, Hall JE, Harding LJ, Chawathe MS. The Cardiff paediatric laryngoscope blade: a comparison with the Miller size 1 and Macintosh size 2 laryngoscope blades. Anaesthesia. 2004 Oct;59(10):1016-9. doi: 10.1111/j.1365-2044.2004.03839.x.
PubMed 15488063Passi 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 25062740Varghese E, Kundu R. Does the Miller blade truly provide a better laryngoscopic view and intubating conditions than the Macintosh blade in small children? Paediatr Anaesth. 2014 Aug;24(8):825-9. doi: 10.1111/pan.12394. Epub 2014 Apr 2.
PubMed 24690084Lingappan K, Arnold JL, Shaw TL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2015 Feb 18;(2):CD009975. doi: 10.1002/14651858.CD009975.pub2.
PubMed 25691129Fiadjoe JE, Gurnaney H, Dalesio N, Sussman E, Zhao H, Zhang X, Stricker PA. A prospective randomized equivalence trial of the GlideScope Cobalt(R) video laryngoscope to traditional direct laryngoscopy in neonates and infants. Anesthesiology. 2012 Mar;116(3):622-8. doi: 10.1097/ALN.0b013e318246ea4d.
PubMed 22270505Levitan RM, Ochroch EA, Kush S, Shofer FS, Hollander JE. Assessment of airway visualization: validation of the percentage of glottic opening (POGO) scale. Acad Emerg Med. 1998 Sep;5(9):919-23. doi: 10.1111/j.1553-2712.1998.tb02823.x.
PubMed 9754506Ochroch EA, Hollander JE, Kush S, Shofer FS, Levitan RM. Assessment of laryngeal view: percentage of glottic opening score vs Cormack and Lehane grading. Can J Anaesth. 1999 Oct;46(10):987-90. doi: 10.1007/BF03013137.
PubMed 10522589
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Miller vs Macintosh Size 0 Blades for Tracheal Intubation of Infants Under 1 Month: a Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT03112798
- Acronym / sponsor ID
- 44140529/2016-50
- Conditions
- Newborn
- Keywords
- tracheal intubation, Macintosh blade, Miller blade
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Istanbul Science UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 1 Nov 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 13 Apr 2017 (actual)
- 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.
Miller blades are commonly used in pediatric anesthesia; however, there is less evidence-based information on the superiority of Miller blades in the visualization of the laryngeal inlet to Macintosh blades. The aim of the present study is to compare the glottic views with the size 0 Macintosh and Miller laryngoscope blades above and below the epiglottis.
Detailed description
Miller blades are commonly used in pediatric anesthesia; however, there is less evidence-based information on the superiority of Miller blades in the visualization of the laryngeal inlet to Macintosh blades (1,2). Therefore prospective randomized comparative studies on this field is required. Passi et al. (3) have demonstrated that, in 50 children aged between 6 months and 2 years, optimal laryngeal views could be obtained with either the Miller size 1 blades lifting the epiglottis or with Macintosh size 1 blades lifting the tongue base. Another clinical trial compared the laryngoscopic views and tracheal intubation conditions with Macintosh and Miller blades in children from 1 month to 24 months. In this study involving 120 children, similar glottic views were obtained with both blades in 43% of the children while a better view was observed with the Miller blade in 29% of the children and with the Macintosh blade in 28% (4). Direct laryngoscopy for tracheal intubation in neonates is a procedure that mostly requires experience and constant practice (5). Neonates have a number of distinctive airway characteristics. These characteristics include the large tongue and head, the floppy, narrow U-shaped epiglottis, the larynx that is located more cephalad, and the vocal cords that are angled in an anterior-caudal position (4). Therefore, straight laryngoscope blades are recommended for use in children and infants under 2 years of age.
In neonatal tracheal intubations, Miller blade is the most frequently utilized blade (6). The reasons for this include the effective displacement of the tongue to the left of the laryngoscope with the Miller blade and the effective lifting of the long and floppy epiglottis during laryngoscopy (3). However, there is no prospective randomized and blinded comparative clinical study on this subject. The aim of the present study is to compare the glottic views with the size 0 Macintosh and Miller laryngoscope blades above and below the epiglottis.
Methods:
For the present study, the Ethics Committee approval was be obtained from the Faculty of Medicine, Istanbul Science University. Written informed consent will be obtained from the parents of patients undergoing elective surgery. The study will involve ASA I or II patients under 1 month. Infants with a history of a difficult airway or diagnosed congenital syndrome, premature infants less than 37 weeks gestational age at birth, and those with acute or chronic pulmonary or neuromuscular diseases will be excluded from the study. Twenty five children undergoing elective surgery will be enrolled in the study. Infants will be randomized (using www.random.com) into two groups, the Miller and Macintosh blade groups, and whether the assigned blade is inserted above or below the epiglottis first, with allocation stored within sealed opaque envelopes until consent is obtained.
In a standard monitoring process, electrocardiogram (ECG), oxygen saturation, non-invasive blood pressure (NIBP), temperature and end-tidal CO2 pressure (EtCO2) will be monitored. Following the monitoring, anesthesia will be induced with 50% air, 50% oxygen and 8% sevoflurane. Once intravenous access is obtained, 0.5 mg/kg rocuronium will be administered. After preoxygenating with 100% oxygen and sevoflurane for 3 minutes, the assigned blade will be inserted into the mouth. All laryngoscopies will be performed by one of three paediatric anesthetists. The Miller blade will be inserted into the mouth at the right commissure and the tongue swept gently to the left. The best laryngeal view will be achieved by optimizing the head position and applying external pressure to the larynx. As described by Passi et al. (3), two laryngeal views will be obtained with the same blade in each patient: lifting the epiglottis or the tongue base. The order of the views (lifting the epiglottis or the tongue base) will be determined by randomization immediately before laryngoscopy. The laryngeal views will be photographed each time by an anesthetist using a digital Olympus camera without using flash. The camera will be optimally positioned before laryngoscopy in order to capture the best possible views. The photos will be reviewed by a blinded anesthetist using the percentage of glottic opening (POGO) score (7,8). This anesthetist will be blinded to the study hypothesis as well as which blade was used and where it was placed. We will photo the child's name and the randomization code-blade type and which view was taken before and after each photo of the larynx. Then the photos will be uploaded and the number of the photo will be recorded in the study record for the child so we will know which photo corresponds to which blade and position for each child. After all the photos are taken, they will be randomized and given to the blinded observer to measure the vocal cord span.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macintosh group | – | –The patients will be intubated by using Macintosh blades and the outcomes will be compared with Miller blades. |
| Miller group | – | –The patients will be intubated by using Miller blades and the outcomes will be compared with Macintosh blades. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will include newborns
Key inclusion criteria (1 listed)
- ASA I or II patients under 1 month.
Key exclusion criteria (1 listed)
- Infants with a history of a difficult airway or diagnosed congenital syndrome, premature infants less than 37 weeks gestational age at birth, and those with acute or chronic pulmonary or neuromuscular diseases will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
POGO scores
Time frame: five months
the laryngeal views will be photographed during laryngoscopy and will be compared
1 secondary outcome
complications
Time frame: five months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Results publication: PubMed 13608313DAVENPORT HT, ROSALES JK. Endotracheal intubation of infants and children. Can Anaesth Soc J. 1959 Jan;6(1):65-74. doi: 10.1007/BF03014197. No abstract available.
- Results publication: PubMed 15488063Jones RM, Jones PL, Gildersleve CD, Hall JE, Harding LJ, Chawathe MS. The Cardiff paediatric laryngoscope blade: a comparison with the Miller size 1 and Macintosh size 2 laryngoscope blades. Anaesthesia. 2004 Oct;59(10):1016-9. doi: 10.1111/j.1365-2044.2004.03839.x.
- Results publication: 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.
- Results publication: PubMed 24690084Varghese E, Kundu R. Does the Miller blade truly provide a better laryngoscopic view and intubating conditions than the Macintosh blade in small children? Paediatr Anaesth. 2014 Aug;24(8):825-9. doi: 10.1111/pan.12394. Epub 2014 Apr 2.
- Results publication: PubMed 25691129Lingappan K, Arnold JL, Shaw TL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2015 Feb 18;(2):CD009975. doi: 10.1002/14651858.CD009975.pub2.
- Results publication: PubMed 22270505Fiadjoe JE, Gurnaney H, Dalesio N, Sussman E, Zhao H, Zhang X, Stricker PA. A prospective randomized equivalence trial of the GlideScope Cobalt(R) video laryngoscope to traditional direct laryngoscopy in neonates and infants. Anesthesiology. 2012 Mar;116(3):622-8. doi: 10.1097/ALN.0b013e318246ea4d.
- Results publication: PubMed 9754506Levitan RM, Ochroch EA, Kush S, Shofer FS, Hollander JE. Assessment of airway visualization: validation of the percentage of glottic opening (POGO) scale. Acad Emerg Med. 1998 Sep;5(9):919-23. doi: 10.1111/j.1553-2712.1998.tb02823.x.
- Results publication: PubMed 10522589Ochroch EA, Hollander JE, Kush S, Shofer FS, Levitan RM. Assessment of laryngeal view: percentage of glottic opening score vs Cormack and Lehane grading. Can J Anaesth. 1999 Oct;46(10):987-90. doi: 10.1007/BF03013137.
- Individual participant dataSharing planned: Undecided
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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.
Kemal T Saracoglu principal investigator
Istanbul Science University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn, run by Istanbul Science University.
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: status not confirmed, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kemal T Saracoglu, MD (+905385478620, saracoglukt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POGO scores (time frame: five months). 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 NCT03112798, which also lists 8 linked publications.
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 13 Apr 2017.