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

Videolaryngoscopy Versus Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia: Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03747250
Acronym
Videoscopy
Enrollment
501
Registered
2018-11-20
Start date
2019-01-01
Completion date
2021-02-28
Last updated
2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheal Intubation Morbidity

Keywords

Videolaryngoscopy, Laryngoscopy, Tracheal intubation, Success rate

Brief summary

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.

Detailed 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.

Interventions

DEVICEVideolaryngoscopy

In experimental group (interventional group), patients will be intubated with the videolaryngoscope

DEVICEDirect laryngoscopy

In control group (active comparator group), patients will be intubated with the direct laryngoscope

Sponsors

Brno University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The allocation to the group will be randomized in located in closed envelope, that will be opened in the operating theater before anesthesia induction

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
29 Days to 19 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
First intubation attempt success rateIntraoperativelySuccess rate of the first intubation attempt

Secondary

MeasureTime frameDescription
Time for successful intubationIntraoperativelyTime need for intubation from decision to intubate to first end-tidal CO2 wave
Overall intubation success rateIntraoperativelySuccess rate fot intubation
Laryngeal viewIntraoperativelyLaryngeal view scored by Cormack-Lehane grading system
ComplicationsIntraoperativelyIncidence of associated complications during anesthesia induction - desaturation, bradycardia

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026