NCT02977559

Brief Summary

The study compared the Laryngeal Tube Suction Disposable (LTS-D) with the Disposable Laryngeal Mask Ambu® AuraGain™ (DLMA AG) during general anesthesia in pediatric patients. The investigators hypothesized that the LTS-D and the DLMA AG performed similarly during mechanical ventilation despite differences in their structural design.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

1 month

First QC Date

November 28, 2016

Last Update Submit

November 30, 2016

Conditions

Adverse Anesthesia Outcome

Keywords

Laryngeal Tube Suction Ambu AuraGain Leak Pressure

Outcome Measures

Primary Outcomes (1)

  • Leak pressure measure in cm H2O

    60 seconds

Secondary Outcomes (1)

  • Time to insertion a device in seconds

    60 seconds

Study Arms (2)

Laryngeal Tube Suction Disposable

EXPERIMENTAL

Laryngeal Tube Suction Disposable for ventilation

Device: Laryngeal Tube Suction Disposable

Laryngeal Mask Airway AuraGain

EXPERIMENTAL

Laryngeal Mask Airway AuraGain for oxygenation and ventilation

Device: Laryngeal Mask Airway AuraGain

Interventions

Laryngeal Tube Suction DisposableDEVICE

Device for ventilation

Laryngeal Tube Suction Disposable
Laryngeal Mask Airway AuraGainDEVICE

Ventilation device

Laryngeal Mask Airway AuraGain

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients, American Society of Anesthesiologist (ASA) physical status I and II weighing 30 to 10 kg, posted for abdominal surgery under general anesthesia.

You may not qualify if:

  • Infants with active respiratory tract infection anticipated and known difficult airway, lung disease requiring high positive end expiratory pressure, and active gastrointestinal reflux will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

November 28, 2016

First Posted

November 30, 2016

Study Start

March 1, 2017

Primary Completion

April 1, 2017

Study Completion

September 1, 2017

Last Updated

December 1, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share