The Videolaryngoscopy in Small Infants (VISI)

March 4, 2021 updated by: Children's Hospital of Philadelphia

The Videolaryngoscopy in Small Infants (VISI) Trial

Complications related to infant (≤ 1 year) airway management are under-appreciated because of few rigorous and targeted studies. Investigators have recently shown that multiple tracheal intubation (TI) attempts are a key risk factor for intubation-related complications in small children. Tracheal Intubation using Video laryngoscopy (VL) has become popular in anesthesiology practice because of several advantages over conventional direct laryngoscopy (DL). Studies show that VL improves the view of the airway compared to DL, requires fewer intubation attempts, but may take more time to intubate the trachea. This study compares first attempt success of VL to DL in infants presenting for elective surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives:

  • Primary Objective To compare the tracheal intubation (TI) first attempt success rate using VL vs. DL in children ≤ 12 months old.
  • Secondary Objectives To compare the lowest oxygen saturation during tracheal intubation with VL vs. DL.

Study Design:

Prospective, randomized, multi-center parallel group trial

Setting/Participants:

This will be a multi-center study with a minimum of four participating centers. The target population will be children ≤ 12 months age scheduled for elective surgery requiring general anesthesia with endotracheal intubation.

Study Interventions and Measures:

The study intervention will be a 1:1 randomization to perform tracheal intubation with the Storz C-Mac Miller 1 (VL) or the conventional Miller laryngoscope (DL).

Main study outcome measures are as follows:

  • The first intubation attempt success rate with each device
  • The number of attempts for successful intubation with each device
  • Complications associated with intubation

Study Type

Interventional

Enrollment (Actual)

566

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

  • Australia
    • Perth
      • Subiaco, Perth, Australia
        • Princess Margaret Hospital for Children
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

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 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Males or females age 0 to <12 months.
  2. Scheduled for non-cardiac surgery or procedure lasting longer than 30 minutes under general anesthesia where oral endotracheal intubation will be performed by an anesthesiology clinician.
  3. Subject/Parental/guardian permission (informed consent).

Inclusion for clinician participants:

1) Pediatric anesthesia attending, pediatric anesthesia fellows, and anesthesia resident

Exclusion Criteria

  1. History of difficult intubation
  2. History with abnormal airway
  3. Predictive of difficult intubation upon physical examination
  4. Parents/guardians who, in the opinion of the investigator, may be unable to understand or give informed consent

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Video Laryngoscopy for endotracheal (ET) Placement

Device:

Storz C-MAC Video Laryngoscope
Device: Video Laryngoscopy for ET placement
Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
Device: Direct Laryngoscopy for ET Placement
Tracheal Intubation performed with the Miller Blade
Active Comparator: Direct Laryngoscopy for ET Placement

Device:

Miller Laryngoscope
Device: Video Laryngoscopy for ET placement
Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
Device: Direct Laryngoscopy for ET Placement
Tracheal Intubation performed with the Miller Blade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Success in the First Attempt
Time Frame: at the time of intubation
comparing the tracheal intubation (TI) first attempt success rate using VL vs. DL
at the time of intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoxia
Time Frame: At the time of intubation
Comparing the lowest oxygen saturation during tracheal intubation with VL vs. DL
At the time of intubation

Collaborators and Investigators

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

Sponsor

Children's Hospital of Philadelphia

Collaborators

Anesthesia Patient Safety Foundation

Investigators

  • Principal Investigator: John Fiadjoe, MD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 4, 2018

Primary Completion (Actual)

August 19, 2019

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

January 9, 2018

First Posted (Actual)

January 11, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17-014302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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