Positive Pressure Ventilation Through a Laryngeal Mask Ai... | NCT03352375

Studies
Positive Pressure Ventilation Through a Laryngeal Mask Airway in Pediatrics

NCT03352375

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Status

Completed

Last Update Posted

Nov 24, 2017Actual

Enrollment

150Actual

Phase

Not Applicable

Conditions

Pediatric
Anesthesia

Interventions

Orotracheally intubation
Laryngeal Mask Airway

Countries

Not provided

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

Nov 2017

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

May 2015Actual

Primary Completion Date

Sep 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Oct 24, 2017

First Submission Date that Met QC Criteria

Nov 21, 2017

First Posted Date

Nov 24, 2017Actual

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

Nov 21, 2017

Last Update Posted Date

Nov 24, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Canan Tulay ISIL, Principal Investigator, Sisli Hamidiye Etfal Training and Research HospitalPrincipal Investigator

Lead Sponsor

Sisli Hamidiye Etfal Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The investigators aimed to investigate effects of intubation and laryngeal mask airway usage in pediatrics during laparoscopic inguinal hernia repair.

Detailed Description

Considering blood gas analysis, end tidal carbon dioxide measurements and airway changes, the investigators aimed to investigate effects of intubation and laryngeal mask airway usage in pediatrics during laparoscopic inguinal hernia repair in this study.

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

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Orotracheally Intubation	Active Comparator	Intervention:orotracheally intubation	Device: Orotracheally intubation
Laryngeal Mask Airway	Active Comparator	Intervention: Laryngeal Mask Airway	Device: Laryngeal Mask Airway

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Orotracheally intubation	Device	Interventions used for airway safety and ventilation during surgical procedures	Orotracheally Intubation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
end tidal carbon dioxide	A parameter measured during positive pressure ventilation	up to 200 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists physical status I, being scheduled to undergo laparoscopic inguinal hernia.

Exclusion Criteria:

Patients, who did not want to participate, patients with severe airway deformities, patients having increased gastroesophageal regurgitation risk, reactive airway hiatal hernia, peripheric vascular disease, mental retardation, neuropsychiatric illness or an lung infection during the last 6 weeks.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Canan Tulay Isil, MD	Sisli Hamidiye Etfal Training and Research Hospital	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17359400	Background	Sinha A, Sharma B, Sood J. ProSeal as an alternative to endotracheal intubation in pediatric laparoscopy. Paediatr Anaesth. 2007 Apr;17(4):327-32. doi: 10.1111/j.1460-9592.2006.02127.x.

ID	Term
D007442	Intubation, Intratracheal
D058109	Airway Management
D013812	Therapeutics
D007440	Intubation