The Videolaryngoscopy in Small Infants



Status:Recruiting
Healthy:No
Age Range:Any
Updated:1/9/2019
Start Date:June 4, 2018
End Date:December 31, 2020
Contact:John Fiadjoe, MD
Email:FIADJOEJ@email.chop.edu
Phone:(215) 590-3916

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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.

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

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

2. Complete the manikin training and watching study training video

3. Willing to provide professional training and device experiences

4. Scheduled to perform intubation on a consented VISI patient

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

Exclusion for clinician participants:

Anesthesia attending who does not have VL experiences in infant
We found this trial at
4
sites
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: John Fiadjoe, MD
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Phone: 617-355-7737
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Phone: 214-456-6393
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Subiaco, Perth 6008
Phone: 61893408109
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