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The Videolaryngoscopy in Small Infants (VISI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03396432
Recruitment Status : Completed
First Posted : January 11, 2018
Results First Posted : September 21, 2020
Last Update Posted : March 25, 2021
Sponsor:
Collaborator:
Anesthesia Patient Safety Foundation
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Surgery Anesthesia, Endotracheal Device: Video Laryngoscopy for ET placement Device: Direct Laryngoscopy for ET Placement Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 566 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, multi-center parallel group trial
Masking: Single (Outcomes Assessor)
Masking Description: Statistician will be blinded at the time of data analysis.
Primary Purpose: Other
Official Title: The Videolaryngoscopy in Small Infants (VISI) Trial
Actual Study Start Date : June 4, 2018
Actual Primary Completion Date : August 19, 2019
Actual Study Completion Date : December 31, 2020
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Hypoxia [ Time Frame: At the time of intubation ]
    Comparing the lowest oxygen saturation during tracheal intubation with VL vs. DL


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396432


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Australia, Perth
Princess Margaret Hospital For Children
Subiaco, Perth, Australia
Sponsors and Collaborators
Children's Hospital of Philadelphia
Anesthesia Patient Safety Foundation
Investigators
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Principal Investigator: John Fiadjoe, MD Children's Hospital of Philadelphia
  Study Documents (Full-Text)

Documents provided by Children's Hospital of Philadelphia:
Study Protocol and Statistical Analysis Plan  [PDF] July 31, 2018
Informed Consent Form  [PDF] February 26, 2018

More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03396432    
Other Study ID Numbers: 17-014302
First Posted: January 11, 2018    Key Record Dates
Results First Posted: September 21, 2020
Last Update Posted: March 25, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Children's Hospital of Philadelphia:
laryngoscope
intubation
first attempt success
oxygen saturation
 airway management
Videolaryngoscopy
Direct laryngoscopy