A safety and efficacy trial of the SureflO2™ oxygen mask which incorporates a visual gas flow indicator into a standard oxygen mask.

Completed

• Conditions: Oxygen Delivery Errors; Airway Management; Respiratory - Other respiratory disorders / diseases; Anaesthesiology - Other anaesthesiology

• Registration Number: ACTRN12619000323123
• Lead Sponsor: VPAS Group Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-06-27
• Study Start: 2019-03-04
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 249

Inclusion Criteria

* All operative patients scheduled for procedures requiring general anaesthesia OR sedation (in association with local/regional/neuraxial anaesthetic techniques)

* Any patient requiring perioperative oxygen supplementation via medium concentration oxygen mask

* Elective planned surgical patients (no emergencies or non-elective cases).

Exclusion Criteria

* Patients under 18 or over 18 and not capable of consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The anaesthetists' perception of successful or not successful detection of oxygen flow by the device as recorded on a secure online study-specific questionnaire. [Immediately upon application of the intervention and for the duration of use of the mask.];Adverse events serious or non-serious. For example mechanical failure of the device posing an airway risk. A further example would be user technique error in the case of the device being difficult to interpret. Adverse events were to be logged by trained users of the device in the study and the overseeing study nurse and logged onto an online platform. In addition the senior investigator was available at all time in the event of a serious adverse event.[Immediately upon application of the intervention and for the duration of use of the mask.]

Secondary Outcome Measures

Name	Time	Method
Oxygen delivery failure events as assessed and recorded by the anaesthetist administering supplemental oxygen with data entered via the online tool.[Immediately upon application of the intervention and for the duration of use of the mask.]