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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
Scientific title
Miller vs Macintosh size 0 and 1 blades for tracheal intubation of infants under 6 months: a randomized comparative study
Secondary ID [1] 296933 0
NONE
Universal Trial Number (UTN)
U1111-1226-0975
Trial acronym
MMT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
AIRWAY MANAGEMENT 310908 0
TRACHEAL INTUBATION 310909 0
ANAESTHESIA 310910 0
Condition category
Condition code
Anaesthesiology 309576 309576 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 313223 0
Treatment: Devices
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
Control group
Active

Outcomes
Primary outcome [1] 318531 0
Primary outcome of this study is to compare Percentage of glottic opening (POGO) scores of Miller and Machintosh blades.
Timepoint [1] 318531 0
At min 0 after direct laryngoscopy
Secondary outcome [1] 365289 0
the time between two laryngeal views via chronometer
Timepoint [1] 365289 0
at min 0 after direct laryngoscopy
Secondary outcome [2] 365290 0
time between rocuronium administration and tracheal intubation via chronometer
Timepoint [2] 365290 0
at min 0 after direct laryngoscopy
Secondary outcome [3] 365291 0
the time between tracheal intubation and second visualization via chronometer
Timepoint [3] 365291 0
at min 0 after second visualization

Eligibility
Key inclusion criteria
ASA I or II patients
Children under 6 months
Children undergoing surgery under general anesthesia
Minimum age
No limit
Maximum age
6 Months
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21149 0
Turkey
State/province [1] 21149 0
Istanbul

Funding & Sponsors
Funding source category [1] 301508 0
Self funded/Unfunded
Name [1] 301508 0
Kemal Tolga Saracoglu
Address [1] 301508 0
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
Country [1] 301508 0
Turkey
Funding source category [2] 301533 0
Self funded/Unfunded
Name [2] 301533 0
Ayten Saracoglu
Address [2] 301533 0
Marmara Universitesi Tip Fakultesi Anesteziyoloji Ve Reanimasyon Anabilim Dali Fevzi Çakmak Mahallesi, Muhsin Yazicioglu Cd No:10, 34899 Pendik/Istanbul
Country [2] 301533 0
Turkey
Primary sponsor type
Individual
Name
Kemal Tolga Saracoglu
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
Country
Turkey
Secondary sponsor category [1] 301235 0
Individual
Name [1] 301235 0
Ayten Saracoglu
Address [1] 301235 0
Marmara Universitesi Tip Fakultesi Anesteziyoloji Ve Reanimasyon Anabilim Dali Fevzi Çakmak Mahallesi, Muhsin Yazicioglu Cd No:10, 34899 Pendik/Istanbul
Country [1] 301235 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302249 0
Bilim University Ethics Committee Of Clinical Research
Ethics committee address [1] 302249 0
Bilim University Büyükdere Cad. No:120 34394 Esentepe
Sisli / Istanbul
Ethics committee country [1] 302249 0
Turkey
Date submitted for ethics approval [1] 302249 0
10/05/2016
Approval date [1] 302249 0
25/05/2016
Ethics approval number [1] 302249 0
44140529/2016-49

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89578 0
A/Prof Kemal Tolga Saracoglu
Address 89578 0
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
Country 89578 0
Turkey
Phone 89578 0
+902164583000
Fax 89578 0
Email 89578 0
saracoglukt@gmail.com
Contact person for public queries
Name 89579 0
A/Prof Kemal Tolga Saracoglu
Address 89579 0
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
Country 89579 0
Turkey
Phone 89579 0
+905385478620
Fax 89579 0
Email 89579 0
saracoglukt@gmail.com
Contact person for scientific queries
Name 89580 0
A/Prof Kemal Tolga Saracoglu
Address 89580 0
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
Country 89580 0
Turkey
Phone 89580 0
+905385478620
Fax 89580 0
Email 89580 0
saracoglukt@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 943 0
Conference poster
Citation/DOI/link/details [1] 943 0
EAC2018 5th European Airway Management Congress 3-7 December Catania , Sicily/Italy
Attachments [1] 943 0
Results – basic reporting
Results – plain English summary