Clinical Efficacy Evaluation of Supraglottic Airway Device SafeLM™ in Paediatric Population

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia; Supraglottic Airway Efficiency; Paediatric Airway Management
• Intervention / Treatment: Device: SafeLM™ as the airway management device during general anaesthesia

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rufinah Teo; Phone Number: +603-9145 5555; Email: rufinah@hctm.ukm.edu.my

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 50603
    • University of Malaya
    • Contact: Ina Ismiarti Shariffuddin; Phone Number: +603-7967 3502; Email: ismiarti@um.edu.my
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • Universiti Kebangsaan Malaysia
      • Contact: Rufinah Teo, Mb Bch BAO; Phone Number: +603-9145 5555; Email: rufinah@hctm.ukm.edu.my
      • Principal Investigator: Rufinah Teo, Mb Bch BAO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Usage of SafeLM™ as the airway device; SafeLM™ will be the airway device used for ventilation throughout the general anaesthesia period

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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Perioperative
Rate of intraoperative laryngospasm	Presence of intra-operative laryngospasm event	Intraoperative
Rate of intraoperative bronchospasm	Presence of intra-operative bronchospasm event	Intraoperative
Rate of intraoperative desaturation event	Presence of desaturation event with pulse oximeter value of 90 percent and below	Intraoperative
Rate of intraoperative gastric aspiration event	Presence of intra-operative gastric aspiration event	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)	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)	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)	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)	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)	Perioperative

Collaborators and Investigators

• Sponsor: National University of Malaysia
• Collaborators: University of Malaya

Study record dates

Study Major Dates

• Study Start (Estimated): December 2, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: September 23, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: JEPUKM-JEP-2025-255

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No