NCT06644586

Brief Summary

In this study, we aimed to observe the intubation conditions in patients using Endolarenx video laryngoscope and Macintosh Blade in laryngoscopy to identify the advantages and disadvantages of using video laryngoscopy in pediatric patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

October 14, 2024

Last Update Submit

October 14, 2024

Conditions

Pediatric Patients Undergoing Operation

Keywords

video laryngoscopydirect laryngoscopypediatric patients

Outcome Measures

Primary Outcomes (1)

  • Mean intubation time

    The time from the entry of the laryngoscope into the oral cavity until the appearance of the EtCO2 trace on the capnograph.

Interventions

videolaryngoscopyOTHER

The patients intubated with video laryngoscopy

Direct LaryngoscopyOTHER

The patients intubated with direct laryngoscopy

Eligibility Criteria

Age1 Year - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent elective surgery at Gaziantep University.

You may qualify if:

  • One hundred pediatric patients, aged under 18 years, weighing between 10-40 kg, and classified as American Society of Anesthesiologists (ASA) I-II-III risk group

You may not qualify if:

  • Patients with congenital airway deformities, patients with known or predicted difficult intubation, patients undergoing emergency surgery, patients classified above ASA III, and patients whose parents did not consent were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, 27410, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gaziantep University

Study Record Dates

First Submitted

October 14, 2024

First Posted

October 16, 2024

Study Start

April 1, 2022

Primary Completion

June 1, 2022

Study Completion

August 1, 2022

Last Updated

October 16, 2024

Record last verified: 2024-10

Locations

TU(1)