NCT02938039

Brief Summary

This study will guide the anesthetists regarding the appropriate selection of the LMA in neonatal age group based on scientific basis. This study will add up to existing literature about the safety of LMA usage in neonates and infants. Furthermore it may shed some light on which LMA type will be more feasible and effective for neonatal/ infants usage.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-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
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

October 17, 2016

Last Update Submit

October 17, 2016

Conditions

Laryngeal Masks

Keywords

laryngeal airwaysinfantsneonateschildrenanesthetized

Outcome Measures

Primary Outcomes (1)

  • Airway Leak Pressure

    It will be measured in mmHg unit and the expiratory valve will be closed with a fresh gas flow of 3 l.min-1 until an audible leak is heard, airway pressure will not be allowed to exceed 25 cmH2O), and then released completely

    17 months

Secondary Outcomes (6)

  • Effective airway time

    18 months

  • Ease of insertion

    18 months

  • Success at first attempt

    18 months

  • Oxygen Desaturation less than 90%

    18 months

  • Gastric Insufflation

    18 months

  • +1 more secondary outcomes

Study Arms (2)

Ambu LMA

ACTIVE COMPARATOR

Ambu Laryngeal Mask Airway device of different sizes for age

Device: Ambu LMA

I-Gel LMA

ACTIVE COMPARATOR

I-Gel Laryngeal Mask Airway device of different sizes for age

Device: I-Gel LMA

Interventions

Ambu LMADEVICE

Ambu Laryngeal Mask Airways

Ambu LMA
I-Gel LMADEVICE

I-Gel Laryngeal Mask Airways

I-Gel LMA

Eligibility Criteria

Age1 Day - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Elective surgical procedures
  • No muscle relaxant agents
  • No other comorbidities

You may not qualify if:

  • Emergency surgical procedures
  • Full stomach
  • Subjects with upper respiratory tract infection
  • Failed caudal block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Abdulrahman M Alzahem, MD

    King Saud University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Consultant

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 19, 2016

Study Start

May 1, 2015

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

October 19, 2016

Record last verified: 2016-10