None listed
Conditions
Brief summary
The main purpose of this study is to determine if claimed improvements in a new version of a common medical device are reasonable and if it is appropriate to use these devices instead of the current devices in use (at the Royal Adelaide Hospital)
Interventions
Use of the Guardian CPV (TM) Laryngeal Mask for airway management under anaesthesia:
The TGA approved Guardian CPV (TM) Laryngeal mask is inserted into the patients upper airway via the mouth, to provide a breathing pathway under anaesthesia for various types of surgery. It is used in place of various competitor products which are also TGA approved and used for many standard anaesthesia procedures. According to the study protocol, the device would be used for surgical procedures which are unlike
Use of the Guardian CPV (TM) Laryngeal Mask for airway management under anaesthesia: The TGA approved Guardian CPV (TM) Laryngeal mask is inserted into the patients upper airway via the mouth, to provide a breathing pathway under anaesthesia for various types of surgery. It is used in place of various competitor products which are also TGA approved and used for many standard anaesthesia procedures. According to the study protocol, the device would be used for surgical procedures which are unlikely to exceed 2 hours duration
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Al patients suitable for laryngeal mask anaesthesia undergoing general surgical procedures under anaesthesia care from the nominated investigators
Exclusion criteria
Age less than 18 years (LMA use is not age limited in standard anaesthesia practice). Body Mass Index (BMI) of <18 or > 35 kg/m2. Inability to communicate well with the study staff or comply with the study requirements and restrictions. Inability to understand the Study Information Sheet and provide a written consent to take part in the study. Poor understanding of the procedure. Poor command of the English Language. An anaesthesia procedure which is unlikely to extend beyond 2 hours. Uncontrolled gastro-oesophageal reflux or regurgitation. High risk for aspiration of gastric contents into lungs. Previous difficulty with insertion of an LMA.
Outcome results
None listed