The Videolaryngoscopy in Small Infants (VISI)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Surgery; Anesthesia, Endotracheal

Treatments: Device: Direct Laryngoscopy for ET Placement; Device: Video Laryngoscopy for ET placement

Study type: Interventional

Funder types: Other

Identifiers

NCT03396432

17-014302

Details and patient eligibility

About

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.

Full 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

Enrollment: 566 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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566 participants in 2 patient groups

Video Laryngoscopy for endotracheal (ET) Placement

Active Comparator group

Description:

Device: Storz C-MAC Video Laryngoscope

Treatment:

Device: Direct Laryngoscopy for ET Placement

Device: Video Laryngoscopy for ET placement

Direct Laryngoscopy for ET Placement

Active Comparator group

Description:

Device: Miller Laryngoscope

Treatment:

Device: Direct Laryngoscopy for ET Placement

Device: Video Laryngoscopy for ET placement