NCT01371032

Brief Summary

The purpose of this study is to compare: the standard pediatric intubation instrument (Miller blade) used as direct laryngoscopy during tracheal intubation to the VideoMiller device (the standard pediatric blade with a camera attached, giving indirect view of the vocal cords in the screen). This intubation device is used to place the tube in the trachea to keep the patient breathing during the surgery procedure. The anesthesiologist obtains a better view of the vocal cords looking at the screen provided by the VideoMiller.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

September 21, 2021

Completed
Last Updated

September 21, 2021

Status Verified

August 1, 2021

Enrollment Period

4.5 years

First QC Date

June 9, 2011

Results QC Date

July 8, 2021

Last Update Submit

August 25, 2021

Conditions

Surgeries Undergoing General Anesthesia

Outcome Measures

Primary Outcomes (3)

  • Time to Obtain Glottic View

    Time to obtain glottic view (from initial insertion of laryngoscope blade to obtain glottic view)

    Times following initial insertion of laryngoscope blade to obtain glottic view

  • Intubation Time

    Times following initial insertion of laryngoscope blade to placement of tracheal tube

    Times from insertion of laryngoscope blade to placement of tracheal tube

  • Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform

    Time following initial insertion of laryngoscope blade to confirm w/ CO2 waveform

    Time from initial insertion of laryngoscope blade to confirm w/ CO2 waveform

Secondary Outcomes (3)

  • Glottis Visualization Using POGO Score

    During intubation procedure, up to 3 minutes

  • Glottis Visualization Using Cormack Lehane

    During intubation procedure, up to 3 minutes

  • Number of Participants Intubated With 1 and > 1 Intubation Attempts

    During intubation procedure, up to 3 minutes

Study Arms (2)

Video-Miller laryngoscope

ACTIVE COMPARATOR

using the screen (Video laryngoscopy group)

Device: VideoMiller

Direct laryngoscopy

ACTIVE COMPARATOR

without use the screen (Direct laryngoscopy group)

Device: Direct Laryngoscopy

Interventions

VideoMillerDEVICE

Video-Miller laryngoscope, using the screen (Video laryngoscopy group)

Video-Miller laryngoscope
Direct LaryngoscopyDEVICE

Video-Miller laryngoscope, without screen (Direct laryngoscopy group)

Direct laryngoscopy

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients aged 3 years or younger undergoing anesthesia requiring endotracheal intubation.
  • Obtaining signed the informed consent by their parents or legal guardian.
  • American Society of Anaesthesiologists (ASA) physical status classification I - II or III

You may not qualify if:

  • Patients deemed to be at significant airway risk necessitating an awake fiber optic intubation
  • Patients with facial abnormalities, and/or oral-pharyngeal malformation.
  • Emergency operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars Sinai Medical center

Los Angeles, California, 90048, United States

Location

Related Publications (1)

  • Lingappan K, Neveln N, Arnold JL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2023 May 12;5(5):CD009975. doi: 10.1002/14651858.CD009975.pub4.

    PMID: 37171122DERIVED

Results Point of Contact

Title
Dr. Roya Yumul, MD, PhD
Organization
Cedars Sinai Medical Center
Roya.Yumul@cshs.org
310-423-1682

Study Officials

  • Roya Yumul, MD,PhD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

  • Ronald H Wender, MD

    Cedars-Sinai Medical Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Residency program director, Department of anesthesiology

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 10, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 21, 2021

Results First Posted

September 21, 2021

Record last verified: 2021-08

Locations

US(1)