NCT03112798

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

March 23, 2017

Last Update Submit

April 8, 2017

Conditions

Newborn

Keywords

tracheal intubationMacintosh bladeMiller blade

Outcome Measures

Primary Outcomes (1)

  • POGO scores

    the laryngeal views will be photographed during laryngoscopy and will be compared

    five months

Secondary Outcomes (1)

  • complications

    five months

Study Arms (2)

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.

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The study population will include newborns

You may qualify if:

  • ASA I or II patients under 1 month.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 13608313RESULT

  • Jones 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.

    PMID: 15488063RESULT

  • 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.

    PMID: 25062740RESULT

  • Varghese 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.

    PMID: 24690084RESULT

  • Lingappan 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.

    PMID: 25691129RESULT

  • Fiadjoe 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.

    PMID: 22270505RESULT

  • Levitan 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.

    PMID: 9754506RESULT

  • Ochroch 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.

    PMID: 10522589RESULT

Study Officials

  • Kemal T Saracoglu

    Istanbul Science University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kemal T Saracoglu, MD

CONTACT

+905385478620saracoglukt@gmail.com

Ayten Saracoglu, MD

CONTACT

+905377810144anesthesiayten@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor MD

Study Record Dates

First Submitted

March 23, 2017

First Posted

April 13, 2017

Study Start

May 1, 2017

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

April 13, 2017

Record last verified: 2017-04