Comparison of Video Laryngoscopy and Macintosh Laryngosco... | NCT06644586

Studies
Comparison of Video Laryngoscopy and Macintosh Laryngoscopy in Pediatric Patients Undergoing Elective Surgery

NCT06644586

Sponsor

University of Gaziantep

Status

Completed

Last Update Posted

Oct 16, 2024Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Pediatric Patients Undergoing Operation

Interventions

videolaryngoscopy
Direct Laryngoscopy

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Actual

Primary Completion Date

Jun 1, 2022Actual

Completion Date

Aug 1, 2022Actual

First Submitted Date

Oct 14, 2024

First Submission Date that Met QC Criteria

Oct 14, 2024

First Posted Date

Oct 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2024

Last Update Posted Date

Oct 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
videolaryngoscopy	Other	The patients intubated with video laryngoscopy
Direct Laryngoscopy	Other	The patients intubated with direct laryngoscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

13 Years

Standard Ages

Child

Study Population

Patients who underwent elective surgery at Gaziantep University.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziantep University		Gaziantep		27410	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided