Conventional Direct Laryngoscopy Vs. Video Laryngoscopy With The C-MAC For Pyloromyotomy
Phase: NA
Conditions: Pyloric Stenosis, Intubation, Pediatric
Sponsor: Indiana University

Revision Date: 8/22/2018 
 
 
 
 
 
 
 
 
Conventional Direct Laryngoscopy Vs. Video Laryngoscopy With The 
C-MAC For Pyloromyotomy 
 
Dr. Nicole Horn 
Department of Pediatric Anesthesiology 
Riley Hospital for Children 
705 Riley Hospital Dr. Room 2001 
Indianapolis, IN  46202 
 
Version 4.0 
Dated: 8/22/2018 
 
NCT02775214 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Revision Date: 8/22/2018 
 
 
 
 
 
Table of Contents: 
 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Inclusion/Exclusion Criteria 
4.0 
Enrollment/Randomization 
5.0 
Study Procedures 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
7.0 
Study Withdrawal/Discontinuation 
8.0 
Statistical Considerations 
9.0 
Privacy/Confidentiality Issues 
10.0 Follow-up and Record Retention 
 
 

Revision Date: 8/22/2018 
1.0 
Background 
 
Infantile hypertrophic pyloric stenosis is a condition caused by marked hypertrophy and 
hyperplasia of the muscular layers of the pylorus.  Pyloric stenosis occurs in 
approximately 1 out of every 300 live births in the United States.  The highest incidence 
is in first born male children, specifically those who had an affected parent.  The age of 
presentation ranges from 3 to 12 weeks, with 95% presenting at 8 weeks.  Infants exhibit 
symptoms of non-bilious, projectile vomiting shortly after feeding.  Pyloric stenosis can 
mimic failure to thrive and results in a hypochloremic, hyponatremic, metabolic alkalosis, 
and in severe cases of dehydration, metabolic acidosis.  Treatment requires surgical 
pyloromyotomy. 
 
During induction of anesthesia for the surgical pyloromyotomy, direct laryngoscopy is 
the primary method for securing an airway in the operating room.  Any infant with the 
diagnosis of pyloric stenosis is considered to be at risk for aspiration of gastric contents, 
and therefore, requires a rapid sequence intubation for securing the airway.  Rapid 
sequence intubation is challenging in infants and leads to frequent oxygen desaturation, 
perhaps even more frequent at a teaching institution, where resident anesthesiologists are 
securing the airway. With the introduction of the video laryngoscope, the staff 
anesthesiologist is able to have direct vision as the resident anesthesiologist secures the 
airway. This allows for early advice and intervention by the staff anesthesiologist.  We 
hypothesize that the video laryngoscope will have a decreased incidence of oxygen 
desaturation when compared to conventional laryngoscopy in this patient population. 
    
2.0 
Rationale and Specific Aims 
 
Specific Aims of this study include determining if there is a difference in the desaturation 
rates of the two different intubation techniques.  Also, is there is a difference in 
intubation success between the two techniques, does intubation success vary with 
different training levels, and does desaturation rate differ amongst training levels. 
 
3.0 
Inclusion/Exclusion Criteria 
 
Inclusion Criteria:  
• Need general anesthesia for pyloromyotomy procedure 
• Have been informed of the nature of the study and informed consent has been 
obtained from the legally responsible guardian 
 
Exclusion Criteria: 
• Abnormal/difficult airway 
• Allergy to succinylcholine and/or propofol 
 
 
5.0 
Enrollment/Randomization 
 
Patients will be enrolled in the study on the day of surgery, in a private setting- including 
but not limited to: pre-operative waiting area, pre-operative holding, or patient’s hospital 

Revision Date: 8/22/2018 
room.  The study will be explained by a member of the research team with extensive 
knowledge of the protocol.  Randomization will occur for each patient using a computer 
randomized list to one of two groups.  One group will be conventional laryngoscopy and 
the other will be video laryngoscopy.  The study seeks to enroll 36 subjects to each 
group. 
 
4.0 
Study Procedures 
 
1. Study design: The study will be randomized, controlled, and prospective in 
design. 
2. Comparison groups  The two comparison groups will be: 
a. Conventional Laryngoscopy (DL), N = 35 
Endotracheal intubation will be performed by conventional direct 
laryngoscopy. 
b.  Video Laryngoscopy (CMAC), N = 37 
Endotracheal intubation will be performed by video laryngoscopy with 
the C-MAC. 
3. Study and timeline of interventions 
a. Preoperative:  All patients enrolled in this study will receive an 
intravenous catheter preoperatively. 
b. Intraoperative:  Subjects will all undergo induction of anesthesia by 
rapid sequence intubation.  Upon arrival to the operating room, a new 
pulse oximeter probe will be placed on the patient’s big toe.  
Orogastric suctioning with a 10 French Salem sump will be done with 
the patient supine, right and left lateral positions.   Preoxygenation 
with 100% oxygen will be undertaken for approximately one minute.  
After pre-oxygenation, a rapid sequence induction will occur with 
Propofol 2.5mg/kg and Succinylcholine 2.5mg/kg IV.  The resident 
will two- hand mask the patient and the staff anesthesiologist will 
manually ventilate the patient maintaining airway pressures less than 
15mmHG.  Approximately twenty seconds after administration of 
succinylcholine, direct laryngoscopy with a Miller 1 blade or a CMAC 
0 blade with be undertaken.  The patient will be intubated with a 3.0 
cuffed endotracheal tube that has been loaded with a stylet.  If the 
resident is having difficulty securing the airway, the staff may 
intervene at any point.  The airway will be deemed secure when end 
tidal CO2 x 3 is seen, chest rise is adequate, and bilateral and equal 
breath sounds are heard.  Anesthesia will be maintained with 
sevoflurane.  The patient will be extubated at the conclusion of the 
case when he/she meets extubation criteria. 
c. Postoperative:  All patients will receive routine PACU care.  Pain and 
anxiety scores will be recorded according to routine PACU practice.  
Medication for pain, nausea, and anxiety will be given according to the 
judgment of the anesthesiologist. 
d. Measured end-points: 
i. Level of resident training  
ii. Desaturation below 80% during induction 

Revision Date: 8/22/2018 
iii. Staff intervention needed for intubation 
iv. Number of intubation attempts  
 
 
5.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
 
Adverse events, other than those measured as end points, should be reported to the 
principal investigator, Dr. Nicole Horn at 317-944-9981. 
 
6.0 
Study Withdrawal/Discontinuation 
 
Participants may withdraw at any time before the procedure, and parents will have the 
ability to request that their child’s data be withdrawn at any time prior to data analysis. 
 
7.0 
Statistical Considerations 
 
The primary outcome of the study will be desaturation below 80%.  Resident training 
level, staff intervention required, number of intubation attempts and any adverse events 
will also be recorded.   Our hypothesis is a significantly smaller percentage of patients in 
the CMAC group will desaturate below 80% compared to the DL group.  A two group 
chi-square test with a 0.05 two-sided significance level will have 80% power to detect the 
difference between 30% vs. 5% proportion of O2sat dropping below 80% (odds ratio of 
0.123) when the sample size in each group is 36. 
  
 
8.0 
Privacy/Confidentiality Issues 
 
Participant privacy is an important goal of the researchers.  Only members of the research 
team will have access to identifiable data. Data will be stored in a secure REDCap 
database.  Only members of the research team will have access to REDCap data.  Paper 
copies of PHI will be kept with study charts and paperwork in the locked anesthesiology 
offices until data analysis is completed and the paperwork is no longer needed, or for 7 
years per Indiana law. 
 
9.0 
Follow-up and Record Retention 
 
The participation in the study begins with induction of anesthesia, and ends when the 
patient is discharged from recovery room.  There will be no patient follow-up after the 
day of the procedure.   
 
The patient data related to the study will be entered into a secure REDCap database.  
Paper copies of study data will be kept in the locked anesthesiology offices. Following 
completion of the study, all copies of data collected will be stored for the required 
amount of time (min. 7 years) and then will be physically destroyed.