AnesthesiaNCT07266389
Clinical Efficacy Evaluation of Supraglottic Airway Device SafeLM™ in Paediatric Population
A study testing SafeLM™ as the airway management device during general anaesthesia in people with Anesthesia and Supraglottic Airway Efficiency, run by National University of Malaysia at 2 sites in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Supraglottic Airway Efficiency, Paediatric Airway Management
- What is being tested?
- SafeLM™ as the airway management device during general anaesthesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesMalaysia
- Study dates
- 2 Dec 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia2 sites
Universiti Kebangsaan Malaysia
Cheras, Kuala Lumpur, 56000
Rufinah Teo, Mb Bch BAO, +603-9145 5555, rufinah@hctm.ukm.edu.my
Rufinah Teo, Mb Bch BAO
University of Malaya
Kuala Lumpur, 50603
Ina Ismiarti Shariffuddin, +603-7967 3502, ismiarti@um.edu.my
About this study
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:
- 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™.
- To determine the incidence of complication associated with SafeLM™ usage.
- To study the association of glottic view with success rate and rate of complication.
Participants perioperative clinical data will be collected for data analysis.
Read the 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.
- Being tested
- SafeLM™ as the airway management device during general anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeLM™ as the airway management device during general anaesthesiaDevice
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 cuff volume to be inflated is 30 to 45 ml Size 5 is for participants with body weight of 70-100 kg, recommended cuff volume to be inflated is 40 to 60 ml.
Under general anaesthesia, the device is held by the anaesthesiologist at the distal end while advancing the laryngeal mask by sliding down the palatopharyngeal curve along the midline in the mouth until the end of the mask reach the hypopharynx cavity and resistance is met, under direct real-time visualisation.
| Study group | Role | What they receive |
|---|---|---|
| Usage of SafeLM™ as the airway device | Experimental | SafeLM™ will be the airway device used for ventilation throughout the general anaesthesia period Receives: Device: SafeLM™ as the airway management device during general anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of device placement in percentage
Percentage of patient experiencing successful insertion of SafeLM™
The criteria of successful insertion:
(i) good chest rise during positive pressure ventilation (ii) no significant air leakage (no audible leak on ausculatation, and the ventilator bellow not collapsing (iii) two or more continuous capnography waveforms (iv) able to achieve a minimum expiratory tidal volume of 6ml/kg
Percetage calculation: number of participants fulfillling successful insertion criteria within 3 insertion attempts divided by total number of participants, multiplied by 100 percents
Measured: Perioperative
Oropharyngeal leak pressure (OPLP) in cmH2O
Oropharyngeal leak pressure (OPLP) is measured and recorded by dialling 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 measurement is done after successful device placement confirmation, once OPLP value is obtained, positive pressure ventilation of spontaneous ventilation will resume.
Measured: From the time of successful device placement confirmation to the time of determination of OPLP before commencement of surgery
Glottic exposure grades
SaCoVLM™ Glottic exposure grades visualised on the videoscope are recorded for each patient Grade 1: Visualization of the lateral part of the right aryepiglottic fold and part of the laryngeal inlet, and the ventilation was good Grade 2: Visualization of the bilateral aryepiglottic fold and part of laryngeal inlet, and the ventilation was good Grade 3: Visualization of all laryngeal inlet and posterior glottis Grade 4: Visualization of the whole glottis
Measured: 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 outcomes (12)
Insertion time in seconds (s)
Time taken for device insertion. 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 is measured using stopwatch.
Measured: Periprocedural
The ease of SafeLM™ insertion
The anaesthetist will rate the ease of SafeLM™ insertion using Likert scale of 1 to 5 (1-Very easy, 2- Easy, 3-Somewhat easy, 4-Difficult, 5-Very difficult). Rating is done at the end of general anesthesia service in the operating theatre.
Measured: Perioperative
Anaesthetists' overall satisfactory score
The anaesthetists' overall satisfactory score will be rated using a scale of 1 to 5 (1-Very dissatisfied, 2-Dissatisfied, 3-Neutral, 4-Satisfied, 5-Very satisfied) Rating is done at the end of general anesthesia service in the operating theatre.
Measured: Perioperative
Rate of intraoperative laryngospasm
Presence of intra-operative laryngospasm event
Measured: Intraoperative
Rate of intraoperative bronchospasm
Presence of intra-operative bronchospasm event
Measured: Intraoperative
Rate of intraoperative desaturation event
Presence of desaturation event with pulse oximeter value of 90 percent and below
Measured: Intraoperative
Rate of intraoperative gastric aspiration event
Presence of intra-operative gastric aspiration event
Measured: Intraoperative
Rate of post-extubation gastric aspiration event
Presence of post-extubation gastric aspiration event from the time of extubation to the time of transfer out from Post anaesthesia care unit (PACU)
Measured: Perioperative
Rate of post-extubation sore throat event
Presence of post-extubation sore throat event from the time of extubation to the time of transfer out from Post anaesthesia care unit (PACU)
Measured: Perioperative
Rate of post-extubation finding of blood stain
Presence of blood stain on the SafeLM™ or oral cavity upon examination during extubation from the time of extubation to the time of transfer out from Post anaesthesia care unit (PACU)
Measured: Perioperative
Rate of post-extubation laryngospasm
Presence of post-extubation laryngospasm event from the time of extubation to the time of transfer out from Post anaesthesia care unit (PACU)
Measured: Perioperative
Rate of post-extubation bronchospasm
Presence of post-extubation bronchospasm event from the time of extubation to the time of transfer out from Post anaesthesia care unit (PACU)
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start2 Dec 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266389
- Sponsor's protocol ID
- JEPUKM-JEP-2025-255
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy Evaluation of Supraglottic Airway Device SafeLM™ in Paediatric Population
- ClinicalTrials.gov ID
- NCT07266389
- Acronym / sponsor ID
- JEPUKM-JEP-2025-255
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- University of Malaya
- Study start
- 2 Dec 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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™.
- To determine the incidence of complication associated with SafeLM™ usage.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usage of SafeLM™ as the airway device | Experimental | Device: SafeLM™ as the airway management device during general anaesthesiaSafeLM™ will be the airway device used for ventilation throughout the general anaesthesia period |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SafeLM™ as the airway management device during general anaesthesiaAppropriate 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 cuff volume to be inflated is 30 to 45 ml Size 5 is for participants with body weight of 70-100 kg, recommended cuff volume to be inflated is 40 to 60 ml. Under general anaesthesia, the device is held by the anaesthesiologist at the distal end while advancing the laryngeal mask by sliding down the palatopharyngeal curve along the midline in the mouth until the end of the mask reach the hypopharynx cavity and resistance is met, under direct real-time visualisation. | Device | Usage of SafeLM™ as the airway device |
Primary outcome
Success rate of device placement in percentage
Time frame: Perioperative
Percentage of patient experiencing successful insertion of SafeLM™ The criteria of successful insertion: (i) good chest rise during positive pressure ventilation (ii) no significant air leakage (no audible leak on ausculatation, and the ventilator bellow not collapsing (iii) two or more continuous capnography waveforms (iv) able to achieve a minimum expiratory tidal volume of 6ml/kg Percetage calculation: number of participants fulfillling successful insertion criteria within 3 insertion attempts divided by total number of participants, multiplied by 100 percents
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
Oropharyngeal leak pressure (OPLP) is measured and recorded by dialling 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 measurement is done after successful device placement confirmation, once OPLP value is obtained, positive pressure ventilation of spontaneous ventilation will resume.
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.
SaCoVLM™ Glottic exposure grades visualised on the videoscope are recorded for each patient Grade 1: Visualization of the lateral part of the right aryepiglottic fold and part of the laryngeal inlet, and the ventilation was good Grade 2: Visualization of the bilateral aryepiglottic fold and part of laryngeal inlet, and the ventilation was good Grade 3: Visualization of all laryngeal inlet and posterior glottis Grade 4: Visualization of the whole glottis
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SafeLM™ as the airway management device during general anaesthesia in people with Anesthesia and Supraglottic Airway Efficiency, run by National University of Malaysia at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rufinah Teo (+603-9145 5555, rufinah@hctm.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of device placement in percentage (time frame: Perioperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.