Back to resultsConventional Direct Laryngoscopy Vs. Video Laryngoscopy With The C-MAC For Pyloromyotomy
Primary Purpose
Pyloric Stenosis, Intubation, Pediatric
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Laryngoscopy
Sponsored by
About this trial
This is an interventional other trial for Pyloric Stenosis focused on measuring Storz C-MAC, direct laryngoscopy, pyloromyotomy, rapid sequence
Eligibility 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
Sites / Locations
- Riley Hospital for Children at IU Health
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Conventional Direct Laryngoscopy
Video Laryngoscopy
Arm Description
Endotracheal intubation will be performed by conventional direct laryngoscopy.
Endotracheal intubation will be performed by video laryngoscopy with the C-MAC.
Outcomes
Primary Outcome Measures
Desaturation below 80%
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02775214
Brief Title
Conventional Direct Laryngoscopy Vs. Video Laryngoscopy With The C-MAC For Pyloromyotomy
Official Title
Conventional Direct Laryngoscopy Vs. Video Laryngoscopy With The C-MAC For Pyloromyotomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare two different ways of placing breathing tubes for surgery. Both ways are used currently to place breathing tubes and are safe and effective. This study seeks to determine if one way is better than the other for infants with pyloric stenosis.
Detailed Description
Specific aims of this study include determining if there is a difference in the desaturation rates of the two different intubation techniques- Direct Laryngoscopy and the C-MAC video laryngoscope. Also is there a difference in intubation success between the two techniques, does intubation success vary with different training levels, and does desaturation rate differ among training levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyloric Stenosis, Intubation, Pediatric
Keywords
Storz C-MAC, direct laryngoscopy, pyloromyotomy, rapid sequence
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional Direct Laryngoscopy
Arm Type
No Intervention
Arm Description
Endotracheal intubation will be performed by conventional direct laryngoscopy.
Arm Title
Video Laryngoscopy
Arm Type
Active Comparator
Arm Description
Endotracheal intubation will be performed by video laryngoscopy with the C-MAC.
Intervention Type
Device
Intervention Name(s)
Video Laryngoscopy
Other Intervention Name(s)
C-MAC
Primary Outcome Measure Information:
Title
Desaturation below 80%
Time Frame
During intubation
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Horn, MD
Organizational Affiliation
Sponsor-Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riley Hospital for Children at IU Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
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Conventional Direct Laryngoscopy Vs. Video Laryngoscopy With The C-MAC For Pyloromyotomy
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