NCT02775214

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 1, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

8.9 years

First QC Date

May 13, 2016

Results QC Date

June 13, 2023

Last Update Submit

October 9, 2023

Conditions

Pyloric StenosisIntubation, Pediatric

Keywords

Storz C-MACdirect laryngoscopypyloromyotomyrapid sequence

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Had Desaturation Below 80% During Intubation

    Patient had a desaturation below 80% during intubation with either conventional laryngoscope or video laryngoscope

    During intubation attempt (less than two minutes)

Study Arms (2)

Conventional Direct Laryngoscopy

NO INTERVENTION

Endotracheal intubation will be performed by conventional direct laryngoscopy.

Video Laryngoscopy

ACTIVE COMPARATOR

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

Device: Video Laryngoscopy

Interventions

Video LaryngoscopyDEVICE
Also known as: C-MAC
Video Laryngoscopy

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Pyloric Stenosis

Condition Hierarchy (Ancestors)

Gastric Outlet ObstructionStomach DiseasesGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
Dr Nicole Horn
Organization
Riley Hospital for Children at Indiana University Health
nhorn@iuhealth.org
3179449981

Study Officials

  • Nicole Horn, MD

    Sponsor-Investigator

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pediatric anesthesiologist

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 17, 2016

Study Start

September 1, 2013

Primary Completion

July 12, 2022

Study Completion

July 12, 2022

Last Updated

November 1, 2023

Results First Posted

November 1, 2023

Record last verified: 2023-10

Locations

US(1)