Conventional Direct Laryngoscopy Vs. Video Laryngoscopy With The C-MAC For Pyloromyotomy

Not Applicable

Terminated

• Conditions: Pyloric Stenosis; Intubation, Pediatric
• Interventions: Device: Video Laryngoscopy

• Registration Number: NCT02775214
• Lead Sponsor: Indiana University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-05-13
• Study First Posted: 2016-05-17
• Primary Completion: 2022-07-12
• Study Completion: 2022-07-12
• Results First Submitted: 2023-06-13
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-09
• Last Update Submitted: 2023-10-09
• Results First Posted: 2023-11-01
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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

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Exclusion Criteria

• Abnormal/difficult airway
• Allergy to succinylcholine and/or propofol

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video Laryngoscopy	Video Laryngoscopy	Endotracheal intubation will be performed by video laryngoscopy with the C-MAC.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Had Desaturation Below 80% During Intubation	During intubation attempt (less than two minutes)	Patient had a desaturation below 80% during intubation with either conventional laryngoscope or video laryngoscope

Trial Locations

Locations (1)

Riley Hospital for Children at IU Health; 🇺🇸 Indianapolis, Indiana, United States