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

NCT07266389 | Not Yet Recruiting

• 1 other identifier: JEPUKM-JEP-2025-255
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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. 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. 2.To determine the incidence of complication associated with SafeLM™ usage.
3. 3.To study the association of glottic view with success rate and rate of complication.

Conditions

Anesthesia; Supraglottic Airway Efficiency; Paediatric Airway Management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Insertion time in seconds (s)

  Periprocedural

• The ease of SafeLM™ insertion

  Perioperative

• Anaesthetists' overall satisfactory score

  Perioperative

• Rate of intraoperative laryngospasm

  Intraoperative

• Rate of intraoperative bronchospasm

  Intraoperative

Study Arms (1)

Usage of SafeLM™ as the airway device

EXPERIMENTAL

SafeLM™ will be the airway device used for ventilation throughout the general anaesthesia period

Device: SafeLM™ as the airway management device during general anaesthesia

Interventions

SafeLM™ as the airway management device during general anaesthesia DEVICE

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.

Usage of SafeLM™ as the airway device

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead
• University of Malaya: collaborator

Study Sites (2)

Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

University of Malaya

Kuala Lumpur, 50603, Malaysia

Location

Central Study Contacts

Rufinah Teo

CONTACT

+603-9145 5555; rufinah@hctm.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: December 5, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

MY (2)