Clinical Efficacy Evaluation of Supraglottic Airway Device SafeLM™ in Paediatric Population
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-18
SponsorNational University of Malaysia
About this trial
The goal of this interventional study is to evaluate the clinical efficacy of SafeLM™, a video laryngeal mask airway device in paediatric population. The main questions it aims to answer are:
1. To determine the success rate, ease of device insertion, time for insertion, and how well the device seals the airway by measuring the oropharyngeal leak pressure (OPLP) of SafeLM™. 2. To determine the incidence of complication associated with SafeLM™ usage. 3. To study the association of glottic view with success rate and rate of complication.
Participants perioperative clinical data will be collected for data analysis.
Eligibility criteria
Qualifiers
Patients who are scheduled for a surgery under general anaesthesia where supraglottic airway is deemed appropriate.
ASA I or II
Age up to 18 years old
Body weight of 10 kg and above
Disqualifiers
Presence of risk of gastric regurgitation or aspiration
Recent upper respiratory tract infection within 2 weeks
Uncontrolled respiratory co-morbidity such as bronchial asthma, chronic lung disease, restrictive lung disease
Presence of congenital airway abnormalities
Trial design
Treatments tested in this trial
- SafeLM™ as the airway management device during general anaesthesia
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
National University of Malaysia
Lead sponsor
University of Malaya
Collaborator
Source ClinicalTrials.gov