NCT03352375

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

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

May 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

October 24, 2017

Last Update Submit

November 21, 2017

Conditions

PediatricAnesthesia

Outcome Measures

Primary Outcomes (1)

  • end tidal carbon dioxide

    A parameter measured during positive pressure ventilation

    up to 200 minutes

Study Arms (2)

Orotracheally Intubation

ACTIVE COMPARATOR

Intervention:orotracheally intubation

Device: Orotracheally intubation

Laryngeal Mask Airway

ACTIVE COMPARATOR

Intervention: Laryngeal Mask Airway

Device: Laryngeal Mask Airway

Interventions

Orotracheally intubationDEVICE

Interventions used for airway safety and ventilation during surgical procedures

Orotracheally Intubation
Laryngeal Mask AirwayDEVICE

Interventions used for airway safety and ventilation during surgical procedures

Laryngeal Mask Airway

Eligibility Criteria

Age1 Year - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 17359400BACKGROUND

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, IntratrachealAirway ManagementTherapeuticsIntubationInvestigative TechniquesMasksProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Canan Tulay Isil, MD

    Sisli Hamidiye Etfal Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: All pediatric patients, who were scheduled to undergo laparoscopic surgery
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2017

First Posted

November 24, 2017

Study Start

May 1, 2015

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

November 24, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Study data can only be shared without patients names