Clinical Efficacy Evaluation of Supraglottic Airway Device SafeLM™ in Paediatric Population (NCT07266389) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Efficacy Evaluation of Supraglottic Airway Device SafeLM™ in Paediatric Population
Malaysia60 participantsStarted 2025-12-02
Plain-language summary
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.
Who can participate
Age range
0 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Success rate of device placement in percentage
Timeframe: Perioperative
2
Oropharyngeal leak pressure (OPLP) in cmH2O
Timeframe: From the time of successful device placement confirmation to the time of determination of OPLP before commencement of surgery
3
Glottic exposure grades
Timeframe: 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.