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Trial registered on ANZCTR
Registration number
ACTRN12619000151134
Ethics application status
Approved
Date submitted
7/01/2019
Date registered
1/02/2019
Date last updated
1/02/2019
Date data sharing statement initially provided
1/02/2019
Date results information initially provided
1/02/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Miller vs Macintosh size 0 and 1 blades for tracheal intubation of infants under 6 months: a randomized comparative study
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Scientific title
Miller vs Macintosh size 0 and 1 blades for tracheal intubation of infants under 6 months: a randomized comparative study
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Secondary ID [1]
296933
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NONE
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Universal Trial Number (UTN)
U1111-1226-0975
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Trial acronym
MMT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
AIRWAY MANAGEMENT
310908
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TRACHEAL INTUBATION
310909
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ANAESTHESIA
310910
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Condition category
Condition code
Anaesthesiology
309576
309576
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0
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Other anaesthesiology
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Forty 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. The straight Miller laryngoscope blade is traditionally recommended for intubation in infants, due to the large size and flexibility of the infant and the Macintosh is the predominate model of the curved blade types. After standart anesthesia induction the assigned blade will be inserted into the mouth. All laryngoscopies will be performed by one of three paediatric anaesthetists. 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., 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 anaesthetist 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 anaesthetist using the percentage of glottic opening (POGO) score . This anaesthetist 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.
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Intervention code [1]
313223
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Treatment: Devices
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Comparator / control treatment
Macintosh blades
Miller blades are commonly used in paediatric anaesthesia; however, there is less evidence-based information on the superiority of Miller blades in the visualization of the laryngeal inlet to Macintosh blades
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Control group
Active
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Outcomes
Primary outcome [1]
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Primary outcome of this study is to compare Percentage of glottic opening (POGO) scores of Miller and Machintosh blades.
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Assessment method [1]
318531
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Timepoint [1]
318531
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At min 0 after direct laryngoscopy
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Secondary outcome [1]
365289
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the time between two laryngeal views via chronometer
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Assessment method [1]
365289
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Timepoint [1]
365289
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at min 0 after direct laryngoscopy
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Secondary outcome [2]
365290
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time between rocuronium administration and tracheal intubation via chronometer
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Assessment method [2]
365290
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Timepoint [2]
365290
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at min 0 after direct laryngoscopy
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Secondary outcome [3]
365291
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the time between tracheal intubation and second visualization via chronometer
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Assessment method [3]
365291
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Timepoint [3]
365291
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at min 0 after second visualization
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Eligibility
Key inclusion criteria
ASA I or II patients
Children under 6 months
Children undergoing surgery under general anesthesia
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Minimum age
No limit
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Maximum age
6
Months
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Children with a history of a difficult airway
Children with diagnosed congenital syndrome,
Infants less than 37 weeks gestational age at birth,
Children with acute or chronic pulmonary or neuromuscular diseases
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
27/06/2016
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Date of last participant enrolment
Anticipated
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Actual
26/06/2017
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Date of last data collection
Anticipated
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Actual
26/06/2017
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Sample size
Target
40
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Accrual to date
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Final
40
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Recruitment outside Australia
Country [1]
21149
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Turkey
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State/province [1]
21149
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Istanbul
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Funding & Sponsors
Funding source category [1]
301508
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Self funded/Unfunded
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Name [1]
301508
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Kemal Tolga Saracoglu
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Address [1]
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Saglik Bilimleri Universitesi Dr Lutfi Kirdar Kartal Egitim Arastirma Hastanesi Anesteziyoloji Ve Reanimasyon Klnigi Semsi Denizer Cad. E-5 Karayolu yani Cevizli mevkii 34890 Kartal/Istanbul
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Country [1]
301508
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Turkey
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Funding source category [2]
301533
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Self funded/Unfunded
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Name [2]
301533
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Ayten Saracoglu
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Address [2]
301533
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Marmara Universitesi Tip Fakultesi Anesteziyoloji Ve Reanimasyon Anabilim Dali Fevzi Çakmak Mahallesi, Muhsin Yazicioglu Cd No:10, 34899 Pendik/Istanbul
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Country [2]
301533
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Turkey
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Primary sponsor type
Individual
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Name
Kemal Tolga Saracoglu
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Address
Saglik Bilimleri Universitesi Dr Lutfi Kirdar Kartal Egitim Arastirma Hastanesi Anesteziyoloji Ve Reanimasyon Klnigi Semsi Denizer Cad. E-5 Karayolu yani Cevizli mevkii 34890 Kartal Iistanbul
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Country
Turkey
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Secondary sponsor category [1]
301235
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Individual
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Name [1]
301235
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Ayten Saracoglu
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Address [1]
301235
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Marmara Universitesi Tip Fakultesi Anesteziyoloji Ve Reanimasyon Anabilim Dali Fevzi Çakmak Mahallesi, Muhsin Yazicioglu Cd No:10, 34899 Pendik/Istanbul
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Country [1]
301235
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Turkey
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302249
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Bilim University Ethics Committee Of Clinical Research
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Ethics committee address [1]
302249
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Bilim University Büyükdere Cad. No:120 34394 Esentepe
Sisli / Istanbul
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Ethics committee country [1]
302249
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Turkey
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Date submitted for ethics approval [1]
302249
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10/05/2016
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Approval date [1]
302249
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25/05/2016
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Ethics approval number [1]
302249
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44140529/2016-49
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Summary
Brief summary
The aim of the present study is to compare the glottis views with the size 0 and 1 Macintosh and Miller laryngoscope blades above and below the epiglottis. the study was designed observational prospective comparative study.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Kemal Tolga Saracoglu
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Address
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Saglik Bilimleri Universitesi Dr Lutfi Kirdar Kartal Egitim Arastirma Hastanesi Anesteziyoloji Ve Reanimasyon Klnigi Cevizli Mh., Semsi Denizer Cad. E-5 Karayolu Cevizli Mevkii, 34890 Kartal/Istanbul
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Country
89578
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Turkey
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Phone
89578
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+902164583000
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Fax
89578
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Email
89578
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[email protected]
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Contact person for public queries
Name
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A/Prof Kemal Tolga Saracoglu
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Address
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Saglik Bilimleri Universitesi Dr Lutfi Kirdar Kartal Egitim Arastirma Hastanesi Anesteziyoloji Ve Reanimasyon Klnigi Cevizli Mh., Semsi Denizer Cad. E-5 Karayolu Cevizli Mevkii, 34890 Kartal/Istanbul
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Country
89579
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Turkey
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Phone
89579
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+905385478620
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Fax
89579
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Email
89579
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[email protected]
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Contact person for scientific queries
Name
89580
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A/Prof Kemal Tolga Saracoglu
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Address
89580
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Saglik Bilimleri Universitesi Dr Lutfi Kirdar Kartal Egitim Arastirma Hastanesi Anesteziyoloji Ve Reanimasyon Klnigi Cevizli Mh., Semsi Denizer Cad. E-5 Karayolu Cevizli Mevkii, 34890 Kartal/Istanbul
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Country
89580
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Turkey
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Phone
89580
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+905385478620
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Fax
89580
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Email
89580
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Glottic views using a Miller size 0 blade are superior to those from a Macintosh size 0 blade in neonates: a randomized trial.
2021
https://dx.doi.org/10.5114/ait.2021.108561
N.B. These documents automatically identified may not have been verified by the study sponsor.
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