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

October 9, 2023 updated by: Nicole Horn, Indiana University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children at IU Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional Direct Laryngoscopy
Endotracheal intubation will be performed by conventional direct laryngoscopy.
Active Comparator: Video Laryngoscopy
Endotracheal intubation will be performed by video laryngoscopy with the C-MAC.
Device: Video Laryngoscopy
Other Names:
  • C-MAC

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Nicole Horn, MD, Sponsor-Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

July 12, 2022

Study Completion (Actual)

July 12, 2022

Study Registration Dates

First Submitted

May 13, 2016

First Submitted That Met QC Criteria

May 13, 2016

First Posted (Estimated)

May 17, 2016

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1306011553

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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