I-gel Versus Air-Q LMA for Pediatric Patients | NCT04458064

Studies
I-gel Versus Air-Q LMA for Pediatric Patients

NCT04458064

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jul 7, 2020Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Easy Insertion, Complications Ans Suitability of i Gel and Air Q LMA

Interventions

LMA i gel

Countries

Egypt

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

Jul 2020

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

Oct 1, 2018Actual

Primary Completion Date

Jul 1, 2020Actual

Completion Date

Jul 1, 2020Actual

First Submitted Date

Jul 1, 2020

First Submission Date that Met QC Criteria

Jul 1, 2020

First Posted Date

Jul 7, 2020Actual

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

Jul 1, 2020

Last Update Posted Date

Jul 7, 2020Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study targets to compare insertion facility, effect on hemodynamic parameters and effective ventilation using i-gel versus Air-Q LMA for pediatric patients undergoing short-duration surgical procedures.

Detailed Description

The patient were divided into 2 groups. I gel group and Air Q group according to LMA type used to maintain airway ventilation.

The patients were compared according to insertion facility, effect on hemodynamic parameters and effective ventilation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
i gel	Active Comparator	I gel LMA was inserted for all patients	Other: LMA i gel
Air Q LMA	Active Comparator	Air Q LMA was inserted for all patients	Other: LMA i gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LMA i gel	Other	insertion of LMA for maintaining airway during anesthesia	Air Q LMA i gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Supraglottic device success rate	Fitness of LMA for ventilation	60 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA grade I-II
operative time of ≤60 minutes

Exclusion Criteria:

age >10 years
ASA grade ≥II
current or recently resolved upper respiratory tract infection
presence of oropharynx or laryngeal pathologies or congenital anomalies
pathologies inducing reflux or increasing the possibility of aspiration
allergy to anaesthetic or drugs to be used, renal, cardiac or hepatic diseases, or bronchial asthma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided