Videolaryngoscopy vs. Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia (Videoscopy)

Brno University Hospital

Status: Completed

Conditions: Tracheal Intubation Morbidity

Treatments: Device: Direct laryngoscopy; Device: Videolaryngoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03747250

KDAR FN Brno 2018/12

Details and patient eligibility

About

Videolaryngoscopy can lead to superior airway conditions and to the possible higher success compared to standard direct laryngoscopy. Patient will be randomized to the interventional group (videolaryngoscopy) and control group (direct laryngoscopy). The first attempt success rate, time to first end-tidal CO2 (ETCO2) wave, overall success rate, incidence of aspiration, bradycardia, desaturation a overall complications will be monitored.

Full description

Videolaryngoscopy is specialized equipment for airway management, where a camera located at the tip of the laryngoscope blade can visualize also structures that can´t be seen on direct laryngoscopy, co the operator can obtain superior view of aditus laryngis during intubation. Currently videolaryngoscopy is not routinely used for intubation and it is reserved for patients with difficult airway. The aim of the trial is to compare the elective use of videolaryngoscopy versus direct laryngoscopy for elective airway management (tracheal intubation). Patients after informed consent approval will be randomized to the interventional group (videolaryngoscopy) and control group (laryngoscopy). The randomization will be managed by the Institute of Biostatistics and Analyses by the Faculty of medicine, Masaryk university. The primary aim will be the first intubation attempt success rate, the secondary aims will be time to successful intubation (time to first ETCO2 wave), overall success rate, number of intubation attempts, incidence of aspiration, desaturation and incidence of overall complications in all operators, in trainees, residents (5-10 years of practice), consultants (10-15 years of clinical practice) and consultants with over 15 years of clinical practice.

Enrollment: 501 patients

Sex: All

Ages: 29 days to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patients scheduled for elective surgery
• Planned tracheal intubation for airway management during surgery
• Signed informed consent

Exclusion criteria

• Emergency surgery
• Other airway management plan
• age outside the predefined limits
• Informed consent not signed

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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501 participants in 2 patient groups

Videolaryngoscopy

Experimental group

Description:

Pediatric patients undergoing elective surgery with planned tracheal intubation for airway management. The tracheal intubation will be performed with the use of videolaryngoscope

Treatment:

Device: Videolaryngoscopy

Direct laryngoscopy

Active Comparator group

Description:

Pediatric patients undergoing elective surgery with planned tracheal intubation for airway management. The tracheal intubation will be performed with the use of direct laryngoscopy

Treatment:

Device: Direct laryngoscopy