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

NCT ID: NCT02775214

Last Updated: 2023-11-01

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2022-07-12

Brief Summary

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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

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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.

Conditions

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Pyloric Stenosis Intubation, Pediatric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Conventional Direct Laryngoscopy

Endotracheal intubation will be performed by conventional direct laryngoscopy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Video Laryngoscopy

Endotracheal intubation will be performed by video laryngoscopy with the C-MAC.

Group Type ACTIVE_COMPARATOR

Video Laryngoscopy

Intervention Type DEVICE

Interventions

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Video Laryngoscopy

Intervention Type DEVICE

Other Intervention Names

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C-MAC

Eligibility Criteria

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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
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Nicole Horn

pediatric anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicole Horn, MD

Role: PRINCIPAL_INVESTIGATOR

Sponsor-Investigator

Locations

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Riley Hospital for Children at IU Health

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1306011553

Identifier Type: -

Identifier Source: org_study_id

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