None listed
Conditions
Brief summary
Laryngeal masks (LMAs) are ideally suited to support flexible bronchoscopic examination and lavage of the airways. Recently at Starship Children’s Health, concerns arose with a move from reusable LMAs, which have potential infective risks, to a disposable version. Increased resistance to the bronchoscope increases the difficulty and duration of the procedure. This can necessitate additional lubrication and/or the use of scissors to modify the mask- neither measure is ideal. Our goal is to compare available disposable LMA devices (LMA unique, Portex Soft Seal, Boss , AMBU) with the reusable ‘classic LMA’ for efficiency and effectiveness in the paediatric flexible bronchoscopy service. Our bench testing of various LMAs in mannequins allowed selection of those most appropriate to assess in clinical practice. Caregivers of the children on the fortnightly bronchoscopy list will be invited to take part. Children will be randomised to 1 of the disposable devices, and the reusable LMA. The respiratory paediatrician will grade each device for resistance to scope manipulation, laryngeal view and overall ease of use. A formal prospective study would be helpful to assist our own, national and international decision making as recommendations move towards using disposable items where possible. No company is sponsoring this study.
Interventions
4 Disposable LMAs : Unique (Polyvinyl Chloride (PVC) construction) similar in form to the LMA Classic, Portex soft seal(PVC construction also similar form to the LMA Classic), Ambu Aura Once (green preformed curve PVC construction with an inflateable cuff similar to the LMA CLassic), Boss systems (disposable silicone construction very sinilar in construction to the LMA CLassic) are compared to the Classic LMA (high grade medical silicone construction) in an randomised clinical trial in children
4 Disposable LMAs : Unique (Polyvinyl Chloride (PVC) construction) similar in form to the LMA Classic, Portex soft seal(PVC construction also similar form to the LMA Classic), Ambu Aura Once (green preformed curve PVC construction with an inflateable cuff similar to the LMA CLassic), Boss systems (disposable silicone construction very sinilar in construction to the LMA CLassic) are compared to the Classic LMA (high grade medical silicone construction) in an randomised clinical trial in children below the weight of 50Kg. Each child is randomised to one of the disposable LMAs, which is inserted into the airway under general anesthesia for a duration of approximately 10minutes and a flexible bronchscopy is performed via the LMA. The LMA Classic is inserted in the same patient either preceding or following the disposable LMA (during the same general anaesthetic) depending on randomisation order. Bronchoscopy is performed via the LMA Classic also for a duration of approximately 10 minutes. Observations are made throughout both processes and the final LMA removed prior to recovery from general anesthesia.
Sponsors
Katharine Brunette (Young)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 16 Years
Healthy volunteers
No
Inclusion criteria
all children presenting for flexible bronchoscopy at Starship Children's Health between March 2008 and April 2009 or until 100 patients are recruited
Exclusion criteria
weight >50kg children with previous difficult bronchoscopy children deemed too unwell to use an LMA or change an LMA during the procedure patient or caregiver or physician refusal allergy to any material used for the study family or child refusal
Outcome results
None listed