Laryngeal Mask Ambu Aura Once vs. Supreme in Children

Apnea Clinical Trial

Official title:

Ventilation With Laryngeal Mask Ambu Aura Once vs. Supreme in Children

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01718782
• Other study ID #: AN4111 292/4.23
• Status: Withdrawn
• Phase: N/A
• First received: September 27, 2012
• Last updated: May 14, 2014
• Start date: March 2013
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is determine safety and efficiency of mechanical ventilation in children with two different types of single use laryngeal masks (Ambu AuraOnce vs. LMA Supreme). The main interest is leakage pressure of oropharynx and stomach. The null hypothesis is that leakage pressures of Ambu AuraOnce and LMA Supreme are equivalent. The alternative hypothesis is that there is a difference in leakage pressure.

Description:

Before starting surgery patients will be anesthetised and airway managed either with LMA Ambu AuraOnce or Supreme. Ventilation parameters, stomach inflation, and hemodynamic parameters will be measured.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 10 Years

Eligibility

Inclusion Criteria:

• Children aged 1-10 years

• ASA I - III

• Elective procedure in general anaesthesia

• Parental informed consent

Exclusion Criteria:

• Non fasting patient

• Body mass index > 35 kg/m2

• Cervical spine pathologies or peripheral neurologic deficiences

• Malformations of upper airway or head

• Anamnestic hiatus hernia or esophageal reflux

• Status post operation of stomach or esophagus

• Recurrent respiratory infection or obstructive airway disease

• Non elective procedure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea

Intervention

Device:
• laryngeal mask Ambu AuraOnce
airway management and mechanical ventilation with laryngeal mask
• laryngeal mask LMA Supreme
airway management and mechanical ventilation with laryngeal mask

Locations

Country	Name	City	State
Austria	University Hospital Innsbruck	Innsbruck	Tirol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leakage pressure [cmH2O]	After ventilation has been established the leakage pressure will be measured, ie 1min after establishing ventilation	1min	Yes
Secondary	Efficient ventilation [mL],	After ventilation has been established the efficient ventilation, tidal volume and stomach inflation will be measured, ie 3min after establishing ventilation	3min	Yes
Secondary	tidal volume [mL],		3 minutes	Yes
Secondary	stomach insufflation [yes or no]		3 minutes	Yes