Clinical Efficacy Evaluation of Supraglottic Airway Device SafeLM™ in Paediatric Population
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-18
SponsorNational University of Malaysia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
SafeLM™ as the airway management device during general anaesthesia
DeviceAppropriate 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Usage of SafeLM™ as the airway deviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Perioperative2
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.
Time frame
From the time of successful device placement confirmation to the time of determination of OPLP before commencement of surgery3
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
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 outcomes
1
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.
Time frame
Periprocedural2
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.
Time frame
Perioperative3
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.
Time frame
Perioperative4
Rate of intraoperative laryngospasm
Presence of intra-operative laryngospasm event
Time frame
IntraoperativeSponsors and contacts
Click on the lead sponsor to view all of their trials.
National University of Malaysia
Lead sponsor
University of Malaya
Collaborator
Source ClinicalTrials.gov
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