Comparison of the BASKA Airway, a Novel Supraglottic Device, to the LMA Airway in Low Risk Female Patients

NCT ID: NCT01482650

Last Updated: 2012-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-02-29

Brief Summary

The investigators have performed a number of studies on novel airway devices, including an observational study on the performance of a new supraglottic airway named Baska mask. In this new proposed study the investigators would like to compare directly,in a randomized clinical trial, this device with the device the investigators routinely use - the single use laryngeal mask airway - LMA, in female patients undergoing general anaesthesia.

This study will determine which device performs best, as measured by key parameters (insertion success rate, seal pressures, time to and ease of insertion, failure rate, complications etc) as regarding the performance and safety profile of the Baska mask and the LMA.

The investigators have two study hypotheses, namely (1) non-inferiority of first placement attempt success rate of Baska vs LMA; and (2) greater seal pressure of the Baska mask vs LMA.

A number of secondary endpoints will be monitored and analyzed (time to and ease of insertion, failure rate, complications etc).

Detailed Description

Airway management is essential component of the safe and efficient provision of general anaesthesia. Supraglottic airway devices have established place in the airway management.

The Baska mask is a new supraglottic airway device. It bears many of the features of the industry standard - the laryngeal mask airway (LMA), with few potential improvements:

• The cuff is not pressurized thus reducing the risk of oropharyngeal tissue damage.
• Improved cuff seal during the inspiratory phase of positive pressure ventilation which may reduce leak and make ventilation more efficient.
• An improved system for drainage of oropharyngeal contents intended to reduce the rate of lung aspiration.
• The Baska mask is inserted in neutral head position thus reducing the need for neck manipulation.
• There is integrated bite-block to reduce the risk of patients biting and blocking the airway.

The results from the observational study of the performance of the Baska mask are promising and the investigators feel a randomized comparative study against the gold standard device, the Laryngeal Mask Airway (LMA) is justified.

This study is a randomized, single blinded, controlled clinical trial. The participants will be allocated to two groups, in which the investigators will use either a single use LMA device or the Baska mask (single use).

Clinical Research Ethics Committee approval has been obtained. Suitable participants will be recruited after written informed consent and screened for inclusion and exclusion criteria.

Standard anaesthetic preassessment and anaesthesia will be provided.

Consenting patients will be randomly allocated to either of the 2 study groups.

Protocol for airway size selection and attempts at placement will be followed.

The investigators will monitor a number of parameters, including time and ease of insertion, airway seal pressure, airway leak, complications, haemodynamic and ventilatory parameters, ease of removal and other.

Follow up will be performed.

The investigators have two primary hypotheses:

1. That the BASKA mask will have an insertion success rate that is no more than 20% less than that of the single use LMA device.

2. That the seal pressure with the BASKA mask will be 40% higher than that of the single use LMA.

In addition to the above the investigators will evaluate a number of secondary outcomes.

Conditions

Performance and Safety of an Airway Management Device

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Baska mask

Group Type: EXPERIMENTAL

supraglottic airway placement and use

Intervention Type: DEVICE

The investigators will place the device (Baska mask or LMA) according to a pre-defined protocol and monitor its performance intra and postoperatively.

single use laryngeal mask airway (LMA)

Group Type: ACTIVE_COMPARATOR

supraglottic airway placement and use

Intervention Type: DEVICE

The investigators will place the device (Baska mask or LMA) according to a pre-defined protocol and monitor its performance intra and postoperatively.

Interventions

supraglottic airway placement and use

The investigators will place the device (Baska mask or LMA) according to a pre-defined protocol and monitor its performance intra and postoperatively.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Female
• Written informed consent
• ASA 1-3
• No relevant allergies
• Body-mass index (BMI) 20-35
• Age 16-85
• Non-urgent surgery of planned duration 0.25-4 hrs

Exclusion Criteria

• Inability of patient/parent to understand or consent for the trial
• Neck pathology
• Previous or anticipated problems with the upper airway or upper GI tract (reflux, hiatus hernia, oropharyngeal tumour, upper respiratory tract infection in the last 10 days)
• BMI >35
• Predicted or previously documented difficult airway
• Live Pregnancy
• Increased risk for Gastric Aspiration
• Current participation in another Clinical Study

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University College Hospital Galway

OTHER

Sponsor Role: lead

Responsible Party

John Laffey

Professor of Anaesthesia and Critical Care, Consultant Anaesthetist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Laffey, FFARCSI

Role: PRINCIPAL_INVESTIGATOR

National University of Ireland, Galway, and Galway University Hospitals

Locations

Galway University Hospitals

Galway, Galway, Ireland

Countries

Ireland

Other Identifiers

C.A. 650

Identifier Type: -

Identifier Source: org_study_id