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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.

Conditions

Surgery, Anesthesia, Endotracheal

Recruitment Status

Completed

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

Males or females age 0 to <12 months.
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.
Subject/Parental/guardian permission (informed consent).

Inclusion for clinician participants:

1) Pediatric anesthesia attending, pediatric anesthesia fellows, and anesthesia resident

Exclusion Criteria

History of difficult intubation
History with abnormal airway
Predictive of difficult intubation upon physical examination
Parents/guardians who, in the opinion of the investigator, may be unable to understand or give informed consent

Intervention

Intervention Type

Intervention Name

Device

Video Laryngoscopy for ET placement

Device

Direct Laryngoscopy for ET Placement

Phase

Not Applicable

Gender

All

Min Age

N/A

Max Age

12 Months

Download Date

March 25, 2021

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: