The Videolaryngoscopy in Small Infants

Not Applicable

Completed

• Conditions: Surgery; Anesthesia, Endotracheal
• Interventions: Device: Video Laryngoscopy for ET placement; Device: Direct Laryngoscopy for ET Placement

• Registration Number: NCT03396432
• Lead Sponsor: Children's Hospital of Philadelphia

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

Study Timeline

• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-11
• Study Start: 2018-06-04
• Primary Completion: 2019-08-19
• Results First Submitted: 2020-07-13
• Results First Submitted QC: 2020-09-01
• Results First Posted: 2020-09-21
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 566

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct Laryngoscopy for ET Placement	Video Laryngoscopy for ET placement	Device: Miller Laryngoscope
Video Laryngoscopy for endotracheal (ET) Placement	Video Laryngoscopy for ET placement	Device: Storz C-MAC Video Laryngoscope
Video Laryngoscopy for endotracheal (ET) Placement	Direct Laryngoscopy for ET Placement	Device: Storz C-MAC Video Laryngoscope
Direct Laryngoscopy for ET Placement	Direct Laryngoscopy for ET Placement	Device: Miller Laryngoscope

Primary Outcome Measures

Name	Time	Method
Number of Participants With Success in the First Attempt	at the time of intubation	comparing the tracheal intubation (TI) first attempt success rate using VL vs. DL

Secondary Outcome Measures

Name	Time	Method
Hypoxia	At the time of intubation	Comparing the lowest oxygen saturation during tracheal intubation with VL vs. DL

Trial Locations

Locations (5)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Princess Margaret Hospital For Children; 🇦🇺 Subiaco, Perth, Australia

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States