Clinical Efficacy Evaluation of Supraglottic Airway Device SafeLM™ in Paediatric Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SafeLM™ as the airway management device during general anaesthesia.
- Who it may be relevant to
- Registry conditions: Anesthesia, Supraglottic Airway Efficiency, Paediatric Airway Management. Basic parameters: 0 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Paediatric patients who are scheduled for surgery where supraglottic airway is deemed appropriate will be recruited with written consent. Following preoxygenation, application of standard monitors, and induction of general anaesthesia, an appropriate size of SafeLM™ will be inserted according to manufacturer's recommendation. Cuff will be deflated and flattened prior, with the back of laryngeal mask lubricated. The device will be advanced by sliding the laryngeal mask down the palatopharyngeal curve along the midline in the mouth until the end of the mask reach the hypopharynx cavity and resistance is met, with the process visualised in real time through the video camera. If there is malalignment, correction manoeuvre such as jaw trust, head reposition, or mask redirection will be done. Once the distal end of mask reaches the hypopharyngeal cavity, the cuff is inflated with the recommended volume of air according to the manufacturer recommendation, until adequate cuff seal is achieved. Then, the patient is put on either spontaneous or pressure-controlled mechanical ventilation. Successful placement will be confirmed. If insertion difficulty is encountered and the laryngeal mask is required to be taken out from the oral cavity, insertion can be reattempt with the same or different size of SafeLM™ after adequate preoxygenation, and it will be considered as second attempt. If it remains unsuccessful on the 3rd attempt, SafeLM™ insertion will be abandoned, subsequent management will be decided by the attending anaesthetist. Glottic exposure grades at the end of each attempt is recorded. The time for insertion is measured for each attempt, using a stopwatch, by obtaining the duration in between the moment when the anaesthetist starts holding the SafeLM™ device, until the appearance of 2 complete continuous capnography waveform on the monitor. Following successful SafeLM™ insertion, the camera can be removed, and orogastric tube will be inserted via the gastric port only if there is clinical indication. Subsequently, oropharyngeal leak pressure (OPLP) is measured and recorded by dialing the fresh gas flow rate to 3 L/min and putting the adjusting pressure limiting (APL) valve at 40 cmH2O, in manual ventilation mode. The equilibrium pressure that the pressure gauze pointer settles down at is the OPLP. The anaesthesia is maintained using TIVA or volatile agent as per the anaesthetist's discretion, keeping the MAC at least 1.0 or BIS level at 40-60, whichever is applicable. All the patients will receive IV dexamethasone 0.2 mg/kg and IV granisetron 0.02 mg/kg as post operative nausea vomiting (PONV) prophylaxis. At the end of anaesthesia, anaesthetic agent administration is terminated. If non-depolarising neuromuscular blockade is given during anaesthesia, an appropriate dose of reversal agent will be given according to the depth of neuromuscular blockade based on either clinical signs or nerve stimulation examination, whichever applicable. After the adequate neuromuscular blockade reversal is confirmed, the laryngeal mask can be removed at the awake state or deep plane of anaesthesia. Patient will be monitored in the post-anaesthesia care unit for at least 30 minutes prior sending back to the designated ward for continuation of care.
Interventions
- Device SafeLM™ as the airway management device during general anaesthesia
Appropriate size of SafeLM™ is selected for participants as manufacturer recommendation. Size 2 is for participants with body weight of 10-20 kg, recommended cuff volume to be inflated is 10 to 15 ml. Size 2.5 is for participants with body weight of 20-30 kg, recommended cuff volume to be inflated is 14 to 21 ml. Size 3 is for participants with body weight of 30-50 kg, recommended cuff volume to be inflated is 20 to 30 ml. Size 4 is for participants with body weight of 50-70 kg, recommended
Primary outcome measures
- Success rate of device placement in percentage [Time frame: Perioperative]
- Oropharyngeal leak pressure (OPLP) in cmH2O [Time frame: From the time of successful device placement confirmation to the time of determination of OPLP before commencement of surgery]
- Glottic exposure grades [Time frame: At the time of completion of device placement procedure, when the distal end of the cuff reaches the hypopharyngeal cavity, resistance is met, and the cuff is inflated with appropriate volume of air as per manufacturer recommendation.]
Secondary outcome measures (12)
- Insertion time in seconds (s) [Time frame: Periprocedural]
- The ease of SafeLM™ insertion [Time frame: Perioperative]
- Anaesthetists' overall satisfactory score [Time frame: Perioperative]
- Rate of intraoperative laryngospasm [Time frame: Intraoperative]
- Rate of intraoperative bronchospasm [Time frame: Intraoperative]
- Rate of intraoperative desaturation event [Time frame: Intraoperative]
- Rate of intraoperative gastric aspiration event [Time frame: Intraoperative]
- Rate of post-extubation gastric aspiration event [Time frame: Perioperative]
- Rate of post-extubation sore throat event [Time frame: Perioperative]
- Rate of post-extubation finding of blood stain [Time frame: Perioperative]
- Rate of post-extubation laryngospasm [Time frame: Perioperative]
- Rate of post-extubation bronchospasm [Time frame: Perioperative]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- Patient or next of kins refusal in participating this study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Malaysia · 2 centers
- Universiti Kebangsaan Malaysia — Cheras
- University of Malaya — Kuala Lumpur
Identifiers
NCT: NCT07266389 · JEPUKM-JEP-2025-255