Inönü University Department of Anesthesia
Phase: NA
Conditions: Anesthesia, Intubation, Laryngoscopy
Sponsor: Inonu University

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21.12.2016 
The Effect of Placement of A Support Under Shoulders on Laryngeal Visualization With 
C- Mac Miller Video Laryngoscope in The Children Younger Than Two Years Of Age  
Zeynep Koylu Gencay, MD, 
Title: Specialist anaesthesia 
Affiliation: Department of Anaesthesiology and Reanimation, Inonu University, 
School of Medicine, Malatya, Turkey 
Email: zkoylu_44@hotmail.com 
Zekine Begec, MD, 
Title: Professor 
Affiliation: Department of Anaesthesiology and Reanimation, Inonu University, 
School of Medicine, Malatya, Turkey  
Email: zekine.begec@inonu.edu.tr 
Ulku Ozgul, MD, 
Title: Associate professor 
Affiliation: Department of Anaesthesiology and Reanimation, Inonu University, 
School of Medicine, Malatya, Turkey 
Email: ulku.ozgul@ınonu.edu.tr 
Cemil Colak, MD 
Title: Professor 
Affiliation: Department of Biostatistics, and Medical Informatics, Inonu University, 
School of Medicine, Malatya, Turkey 
Email: cemil.colak@inonu.edu.tr 
Corresponding Author:  
Zekine Begec 
Department of Anaesthesiology and Reanimation, Inonu University, School of Medicine, 
Malatya, Turkey 
Zekine.begec@inonu.edu.tr 
Phone: +90 341 06 60/  
Fax: +90 341 07 28 
Conflicts of Interest: None 

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21.12.2016 
Study Protocol 
Patient Selection  
This study was approved by the University's Institutional Review Board (IRB #2016/203) and 
written informed consent will be obtained from the parents of the children participating in the 
trial. This study will be conducted in compliance with the Good Clinical Practice guidelines 
and adheres to the applicable Consolidated Standards of Reporting Trials (CONSORT) 
guidelines.  
96 children younger than two years of age who were classified as ASA I or II and will be 
scheduled for the elective surgery necessitating endotracheal intubation under general 
anesthesia in hospital of Inonu University Faculty of Medicine will be included in the study. 
Children who had an upper respiratory tract infection in the last 4 weeks and who expected to 
have difficult airway in the preoperative evaluation or who will not be stable during intubation 
(due to underlying respiratory or cardiovascular problems), will be excluded from the study. 
Randomization 
The present study will be planned as a prospective and randomized clinical trial. Randomization 
will be performed using the MedCalc package program (www.medcalc.org). A total of 96 cases 
will be randomly divided into two groups. The cases will be intubated by placing a folded towel 
under the shoulder named as Group 1 (n=48), and the cases will be intubated without placement 
of folded towel named as Group 2 (n=48).  
Intubation Protocol 
Age, gender, height, weight, ASA values and preoperative airway evaluation will be noted 
before the children will be taken to the operating room. No premedication was applied to the 
children. Intraoperative monitoring was provided with ECG, non-invasive blood pressure, 
capnography and pulse oximetry. The induction of general anesthesia will be achieved with 
sevoflurane (5% -8%) or thiopental (5-8 mg.kg-1 IV) and fentanyl (1 μg.kg-1 IV) in all children. 
After confirming mask ventilation, rocuronium (0.6 mg / kg-1 IV) will be administered in order 
to facilitate endotracheal intubation. During mask ventilation, shoulders of the children in 
Group 1 will slightly be raised with a folded towel, in the children of Group 2, folded towel 
will not be placed under shoulder.   
Tracheal intubation will be performed using C-MAC Miller VL, after muscle relaxation will be 
confirmed using a neuromuscular monitoring (Organon, Dublin, Ireland). Uncuffed spiral 
Endotracheal tube (ETT) with stylet and appropriate size for age of children, will be used in all 
patients. All tracheal intubations will be performed by a single anesthesiologist who performed 
more than 50 tracheal intubations with C-MAC Miller VL in children.  
 
Study Outcomes  
In our study, the primary outcome will be the POGO score. The percentage of glottis opening 
(POGO) score corresponds to the percentage of visualization of the glottis. A POGO score of 
100% refers to the visualization of entire glottis opening from the anterior commissure of the 
vocal cords to the interarytenoid notch. If no part of the glottis opening is visible, the POGO 

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score is 0%. For the subsequent evaluation of a researcher who was blind to the position of the 
cases, screenshots of glottis will be taken during laryngoscopy with C-MAC Miller VL. 
The secondary outcomes in the study will be the ease of use of the C-MAC VL device, the 
Cormack-Lehane Scores, the time to intubation, the number of intubation attempts, the 
optimization procedures during the endotracheal intubation and the complications. 
The ease of use of the device in this position will be evaluated with a VAS score ranging from 
0 (the most difficult and disturbing use) to 10 (easiest and most comfortable use) by anesthetist 
who used the C-MAC Miller VL device. 
The time to intubation will be recorded as from the time C-MAC Miller VL entered the oral 
cavity until the time the end-tidal CO2 (EtCO2) trace was seen in the capnography. If intubation 
failed, the time of each attempt will be collected and more than three attempts will not be 
allowed. 
The optimization procedures required for successful endotracheal intubation will be recorded 
as external laryngeal compression (displacement of the larynx by backward, upward and right-
ward pressure on the thyroid cartilage, or BURP) and position change (the rotation or vertical 
lifting of C-MAC Miller VL). 
Complications including desaturation (peripheral oxygen saturation <90%), esophageal 
intubation, dental and mucosal damage will be noted. 
Statistical Analysis  
The primary outcome of our study is the POGO score. Based on the study of Kim et al. (8); 
when the estimated POGO score difference between two groups was 20, standard deviation was 
34, type 1 error (alpha) 0.05 was and type 2 error (beta) was 0.20 (power = 0.80), the required 
sample size consisting of at least 94 patients (at least 47 in each group) was calculated by power 
analysis.