Clinical trial NCT03396432: The Videolaryngoscopy in Small Infants
Official title: The Videolaryngoscopy in Small Infants (VISI) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Anesthesia, Endotracheal
Keywords: laryngoscope
intubation
first attempt success
oxygen saturation
airway management
Videolaryngoscopy
Direct laryngoscopy
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Anesthesia Patient Safety Foundation
First posted: 2018-01-11
Enrollment: 566
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, multi-center parallel group trial
Primary purpose: OTHER

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.

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

Eligibility 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

Primary outcomes:
measure: Number of Participants With Success in the First Attempt
timeFrame: at the time of intubation
Secondary outcomes:
measure: Hypoxia
timeFrame: At the time of intubation
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Subiaco
country: Australia
facility: Princess Margaret Hospital For Children
state: Perth
Study officials:
affiliation: Children's Hospital of Philadelphia
name: John Fiadjoe, MD
role: PRINCIPAL_INVESTIGATOR
References:
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